- Email: [email protected]
Single-port laparoscopy in gynecologic oncology: seven years of experience at a single institution
Accepted Manuscript Single Port Laparoscopy in Gynecologic Oncology: Seven Years of Experience at a Single Institution Laura Moulton, DO, MS, Amelia M. Jernigan, MD, Caitlin Carr, MD, Ms. Lindsey Freeman, BS, Pedro F. Escobar, MD, Chad M. Michener, MD PII:
S0002-9378(17)30744-5
DOI:
10.1016/j.ajog.2017.06.008
Reference:
YMOB 11725
To appear in:
American Journal of Obstetrics and Gynecology
Received Date: 16 December 2016 Revised Date:
31 May 2017
Accepted Date: 6 June 2017
Please cite this article as: Moulton L, Jernigan AM, Carr C, Freeman L, Escobar PF, Michener CM, Single Port Laparoscopy in Gynecologic Oncology: Seven Years of Experience at a Single Institution, American Journal of Obstetrics and Gynecology (2017), doi: 10.1016/j.ajog.2017.06.008. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Single Port Laparoscopy in Gynecologic Oncology: Seven Years of Experience at a Single
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Institution
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Laura Moulton, DO, MS1*; Amelia M. Jernigan, MD2; Caitlin Carr, MD1; Ms. Lindsey
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Freeman3, BS; Pedro F. Escobar, MD4, Chad M. Michener, MD5
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Avenue, Cleveland, OH, USA, 44195.
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Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic, 9500
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Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Louisiana State
University Healthcare Network, New Orleans, LA, USA
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Case Western Reserve School of Medicine, Cleveland, OH USA
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Instituto Gyneco-Oncólogico, San Juan 00926, PR
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Division of Gynecologic Oncology, Obstetrics, Gynecology and Women’s Health Institute,
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Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA, 44195.
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* Corresponding Author: Laura J. Moulton, DO, MS; Email: [email protected], Phone: (216)-
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212-2854; Fax: (216)-445-6325
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No financial support obtained for this research.
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The authors report no conflicts of interest.
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These findings were presented at the 43rd Annual Scientific Meeting of the Society of
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Gynecologic Surgeons in San Antonio, TX, March 26-29th.
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Manuscript word count: 2092, Abstract word count: 399, Tables: 4, Figures: 1; Print issue figure:
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Table 3
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Condensation: Single port laparoscopy is associated with low short-term adverse outcomes in
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gynecologic oncology. Risk of incisional hernia may have been previously underestimated.
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Short Title: Single port laparoscopy in gynecologic oncology
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Abstract
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Background: Single port laparoscopy has gained popularity within minimally invasive
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gynecologic surgery for its feasibility, cosmetic outcomes and safety. However, within
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gynecologic oncology, there is limited data regarding short-term adverse outcomes and long term
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hernia risk in patients undergoing single port laparoscopic surgery.
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Objective: To describe short-term outcomes and hernia rates in patients after single port
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laparoscopy in a gynecologic oncology practice.
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Methods: A retrospective, single institution study was performed for patients who underwent
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single port laparoscopy from 2009-2015. Univariate analysis was performed with chi-square tests
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and t-tests; Kaplan Meier and Cox proportional hazards determined time to hernia development.
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Results: 898 patients underwent 908 surgeries with a median follow-up of 37.2 months. The
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mean age and body mass index were 55.7 years and 29.6 kg/m2, respectively. The majority were
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Caucasian (87.9%) and American Society of Anesthesiologists class II/III (95.5%). The majority
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of patients underwent surgery for adnexal masses (36.9%) and endometrial hyperplasia/cancer
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(37.3%). Most women underwent hysterectomy (62.7%) and removal of one or both fallopian
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tubes and/or ovaries (86%). Rate of adverse outcomes within 30 days, including reoperation
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(0.1%), intraoperative injury (1.4%), intensive care unit admission (0.4%), venous
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thromboembolism (0.3%) and blood transfusion, were low (0.8%). The rate of urinary tract
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infection was 2.8%; higher body mass index (p=0.02), longer operative time (p=0.02), smoking
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(p=0.01), hysterectomy (p=0.01), and cystoscopy (p=0.02) increased risk. The rate of incisional
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cellulitis was 3.5%. Increased estimated blood loss (p=0.03) and endometrial cancer (p=0.02)
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were independent predictors of incisional cellulitis. Rate for surgical readmissions was 3.4%;
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higher estimated blood loss (p=0.03), longer operative time (p=0.02), chemotherapy alone
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(p=0.03) and combined chemotherapy and radiation (p<0.05) increased risk. Rate of incisional
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hernia rate was 5.5% (n=50) with a mean occurrence at 570.2 ± 553.3 days. Higher American
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society of Anesthesiologists class (p=0.04), diabetes (p<0.001), hypertension (p=0.043),
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increasing age (p=0.017; HR 1.03) and body mass index (p<0.001; HR 1.08) were independent
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predictors for incisional hernia development. Previous abdominal surgeries (p=0.24) and hand-
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assist (p=0.64) were not associated with increased risk for incisional hernia. Patients with
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American society of Anesthesiologists class III/IV had a 3-year hernia rate of 12.8% (HR 1.81).
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Patients with diabetes mellitus had a 3-year hernia rate of 23.0% (HR 3.60).
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Conclusions: In this large cohort of patients undergoing single port laparoscopy, the incidence of
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short-term adverse outcomes is low. While the rate of incisional hernia was 5.5%, incidence
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reached 23.0% at three years in high-risk groups. Previous studies with short follow up duration
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may underestimate the risk of hernia, especially in patients with significant comorbidities.
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Key words: Single port laparoscopy, minimally invasive surgery, single incision laparoscopy,
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gynecologic oncology, laparoendoscopic single site surgery, adverse outcomes, incisional hernia
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Introduction
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Laparoscopic surgery has become a mainstay within gynecology for completion of many
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procedures for benign and malignant indications. Minimally invasive surgery is associated with
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improved patient quality of life, reduced perioperative morbidity, shorter hospitalization and
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improved recovery time compared to laparotomy.1,2 More recently gynecologists have applied
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single port laparoscopic (SPL) surgery, also known as single-incision laparoscopic surgery
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(SILS) and laparoendoscopic single site surgery (LESS) to common gynecologic problems,
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which allows for a single incision most commonly through the umbilicus.3,4 After it was first
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reported within gynecologic oncology in 2009 by Fader et al. growing data has demonstrated that
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SPL is a feasible and safe minimally invasive platform for the treatment of many gynecologic
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malignancies.5 However, the current literature is limited by small sample sizes of patients or
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short duration of follow-up which precludes making statements regarding long-term outcomes
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and rate of incisional hernia.5-11
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Within gynecologic oncology specifically, there is limited data regarding short-term adverse
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outcomes and long-term hernia risk in patients having SPL. Gunderson et al. performed a
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retrospective review of 211 patients undergoing SPL for benign or malignant gynecologic
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conditions, and 2.4% developed an umbilical hernia at a median duration of 16 months.12 In a
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similar study by Jennings et al., the rate of an incisional hernia was reported at 1.8% within 30
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days, with limited data for the risk at later time points.9 Among other surgical specialties
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performing SPL, incisional hernia rates as high as 33% at 3.5 years have been reported, with
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increasing age and BMI as significant predictors for hernia development.13-16 The objective of
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this study is to describe short-term outcomes and long-term incisional hernia rates in patients
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after single port laparoscopy in a gynecologic oncology practice.
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Methods
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An IRB approved retrospective, single institution study was performed for patients who
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underwent SPL from 2009-2015 with the gynecologic oncology division at Cleveland Clinic
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Foundation. All patients who underwent SPL were identified and included in the study without
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exclusions. No robotic SPL procedures were included in the analysis.
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Three gynecologic oncologists performed the surgeries. Patients underwent surgery through a
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single vertical umbilical incision using the open Hasson approach for abdominal entry. After
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abdominal entry was obtained, a multi-instrument access port was used (GelPOINT and
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GelPORT; Applied Medical, Rancho Santa Margarita, CA) (Figure 1). At the end of each
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operation, the fascia was identified and closed with a delayed absorbable suture (Vicryl, ethicon,
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Cincinnati, OH or Polysorb, Medtronic, minneappolis, MN). Permanent suture was utilized for
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patients with umbilical hernia on abdominal entry or at the surgeons discretion for patients felt to
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be at risk for hernia such as those requiring chemotherapy.
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All data was collected and stored securely within a RedCAP database.17 Data collection included
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patient age, BMI, race, medical comorbidities, surgical history and surgical indication. Operative
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variables included length of surgery, estimated blood loss, length of hospital stay, conversion to
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multi-port laparoscopy or laparotomy and hand-assist. Surgical time was defined as time from
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skin incision to closure. Intraoperative complications were defined as injury to bowel, bladder,
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ureters, nervous or vascular structures. Data was collected for postoperative complications which
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included return to OR in less than 48 hours and unplanned ICU admission, blood transfusion,
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fevers, urinary retention, urinary tract infection, venous thromboembolism (DVT or PE), delayed
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bowel, ureteral or bladder injury, incisional cellulitis, deep wound infection, vaginal cuff
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dehiscence or readmission. Distant outcomes were collected regarding incisional hernia
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development and timing and disease recurrence. Incisional hernia was defined as any hernia that
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was detected clinically during post-operative surveillance with gynecologic oncology, benign
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gynecology, primary care and surgical subspecialties within our hospital electronic medical
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record after surgery either via physical exam or radiographically.
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For statistical analysis, categorical factors were summarized using frequencies and percentages,
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while continuous measures summaries used means and standard deviations. To evaluate risk
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factors for early outcomes, Pearson chi-square tests and two sample t-tests were used, while
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Kaplan Meier estimates and Cox proportional hazards were used to evaluate differences in time
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to hernia development. The variables chosen as potential predictors of hernia-free survival were
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derived in two ways. First, from prior studies that demonstrated possible predictors for hernia
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development after single port laparoscopy in gynecology and general surgery. Secondly,
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variables were derived from literature on hernias for traditional multi-port laparoscopy in
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gynecology and other surgical subspecialties. Risk estimates were provided as odds ratios with
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95% confidence limits for early outcomes, and hazard ratios with 95% confidence limits for time
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to hernia development. Given the small event rate, only factors with at least 40 patients in each
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level were considered as potential predictors. Analysis was performed using SAS software
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(version 9.4; Cary, NC).
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Results
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In total, 908 SPL surgeries were performed in 898 patients and all cases were included in the
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analysis with a median follow-up for the entire cohort of 37.2 months. Ten patients underwent
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two surgeries. Indications for proceeding with two surgeries included surgical staging after
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malignancy identified on risk reducing surgery (n=3), development of contralateral ovarian mass
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(n=3), surgery for recurrent disease (n=2) and completion hysterectomy for cervical carcinoma
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(n=1). Table 1 includes preoperative patient characteristics. The mean age and BMI were
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55.7±13.0 years old and 29.6±7.5 kg/m2, respectively. The majority of patients were Caucasian
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(n=793, 87.9%) or African American (n=86; 9.5%). 12.3% (n=112) had undergone radiation.
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Additionally, eleven patients (1.2%) had received neoadjuvant chemotherapy and 88 (9.7%)
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received adjuvant chemotherapy. Of the 908 surgeries performed, 36.9% (n=335) were
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performed for adnexal masses, 37.3% (n=339) for endometrial hyperplasia or cancer, 14.1%
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(128) for risk reduction for increased risk of breast and ovarian cancer, 13.9% (n=126) for
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history of breast cancer, 4.4% (n=40) for cervical dysplasia or cancer, 5.4% (n=49) for ovarian,
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fallopian tube or peritoneal carcinoma and 0.2 (n=2) for molar pregnancy or gestational
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trophoblastic neoplasia.
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Table 2 includes intraoperative data. For procedures performed, 62.7% (n=569) underwent
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hysterectomy, 82.2% (n=746) right oophorectomy and 80.3% (n=729) left oophorectomy. 126
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patients (13.9%) underwent pelvic lymphadenectomy and 67 patients (7.4%) para-aortic
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lymphadenectomy. Hand-assist surgery was performed in 45 patients (5.0%) with a total
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conversion rate of 3.9% (n=35), with 3.2% of cases converted to laparotomy (n=29) and 0.7%
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(n=6) converted to multi-port laparoscopy. Malignancy requiring surgical staging (n=16; 55.2%,
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dense adhesive disease (n=8; 27.6%), repair of intra-operative injury (n=4; 13.8%) and removal
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of specimen (n=4; 13.8%) were the leading reasons for conversion to laparotomy.
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Dense adhesions (n=3; 50%), malignancy with need for staging (n=1; 16,7%) and repair of intra-
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operative injury (n=1; 16.7%) were the reasons for conversion to multi-port laparoscopy. The
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mean operative time was 121.8±69.1 minutes with mean estimated blood loss of 65.0±114.1 mL.
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Table 3 reports postoperative outcomes, including short-term adverse events and hernia outcome.
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Of 908 surgeries, one patient (0.1%) underwent reoperation within 48 hours, four patients (0.4%)
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had unplanned ICU admission and seven patients (0.8%) received blood transfusion within 30
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days. Within 30 days of surgery, 4.0% (n=37) of patients developed fever >100.4F, 1.7% (n=16)
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had urinary retention, 2.8% (n=26) developed UTI, 0.2% (n=2) developed deep venous
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thrombosis and 0.1% (n=1) developed pulmonary embolism. Three patients had delayed injury
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noted within 30 days of surgery with one patient each developing bowel, bladder or ureteral
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injury (0.1%; n=1), respectively. Within 30 days of surgery, the rate of surgical site infection
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was 4.5% (n=41). 32 patients (3.5%) developed incisional cellulitis, ten patients (1.1%)
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developed a deep wound infection including one patient with concurrent cellulitis. One patient
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(0.1%) had a vaginal cuff dehiscence. Urinary retention within 30 days of surgery was more
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common among patients of increasing age (mean age of 68.6 vs. 55.5 years; p<0.001) and
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patients receiving pelvic radiation (4.5% vs. 1.4%; p=0.038) and adjuvant/neoadjuvant
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chemotherapy (6.4% vs. 1.2%; p=0.004). Postoperative UTI within 30 days of surgery was
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increased among patients with increased BMI (33.0 vs. 29.6; p=0.02), longer operative time
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(152.0 vs. 120.9 minutes; p=0.02), tobacco use (p=0.01) and hysterectomy (p=0.01) and
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cystoscopy (p=0.02). Predictors for development of incisional cellulitis within 30 days of
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surgery were higher estimated blood loss (110.0 vs. 63.5cc; p=0.03) and surgery for endometrial
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cancer (p=0.02). Longer operative time (150.1 vs. 120.8; p=0.02), higher estimated blood loss
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(107.3 vs. 63.5; p=0.03), chemotherapy (p=0.03) and chemotherapy and radiation (p<0.05) were
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associated with increased likelihood of readmission within 30 days.
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The rate of incisional hernia was 5.5% (n=50) with a mean time to hernia development of
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570.2±553.3 days. The total range of time to hernia development was 93 to 1694 days. Among
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patients who developed an incisional hernia, the rate of previous umbilical hernia repair surgery
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was 6.0% (n=3). Significant predictors for hernia formation were increasing age (HR 1.03; 95%
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CI 1.00-1.05; p=0.001) and higher BMI (HR 1.08; 95% CI 1.05-1.11; p<0.001). Among those
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who developed a hernia, rate of post-operative cellulitis was low (n=1; 2.0%).
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Table 4 describes hernia free survival for patients included in the final analysis. For all patients,
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the overall hernia free survival was 95.3% (93.6,97.0), 91.3% (88.8,93.8) and 90.5% (87.8,93.2)
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at 1, 2 and 3 years respectively. Patients with ASA class III/IV had a significantly lower 3-year
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hernia free survival compared to patients classified as ASA I/II (87.2% vs. 93.7%; 95% CI
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1.02,3.19; HR 1.81; p=0.04). Amongst patients with diabetes mellitus, the hernia free survival
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was 92.2% (87.1, 97.5), 79.3% (70.2, 89.5) and 77.0% (67.3, 88.1) at 1, 2 and 3 years
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respectively (p<0.001). Similarly, in patients with hypertension the hernia free survival was
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94.2% (91.4, 97.0), 88.8% (84.7, 93.1) and 87.1% (82.5, 92.0) at 1, 2 and 3 years respectively
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(p=0.04). Patients with obesity, defined as BMI >30, had significantly higher rate of a hernia
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developed with 1, 2 and 3 years hernia free survival of 91.8% (88.4, 95.3), 87.1% (82.5, 91.8)
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and 84.9% (79.6, 90.5), respectively (p<0.001). There was no difference in hernia free survival
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for patients who received chemotherapy alone (HR 1.14; 95% CI 0.47, 2.77), radiation alone
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(HR 1.58; 95% CI 0.78, 3.23), combined chemotherapy and radiation (HR 1.00; 95% CI 0.36,
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2.75) or those who used tobacco products (95% CI 0.48,2.17; HR 1.02).
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Of the 50 patients with post-operative umbilical incisional hernias, 28 patients (56%) underwent
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corrective surgery due to bothersome symptoms, including abdominal pain or bulge sensation.
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Only one procedure (2%) was performed in an emergent manner for an incarcerated hernia. Of
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the 28 surgeries performed, the majority were performed by general surgery (n=27; 96.4%).
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Discussion
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The utility of minimally invasive surgery in the management of gynecologic malignancies is well
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established.1,2 As surgical practices are continually evolving, techniques allowing for safe,
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efficient and cost-effective operations with favorable recovery time are necessary. Since our
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institution first described usage of SPL in gynecologic oncology in 2009, this technique has been
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successfully utilized to perform a multitude of procedures with favorable surgical and cosmetic
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outcomes in women with gynecologic malignancy.5-11 After seven years of experience with this
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surgical technique, this study reports on the largest series of patients undergoing single port
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laparoscopy in gynecologic oncology. Our findings add to the growing body of literature that
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SPL is a safe and feasible method to perform a variety of procedures for gynecologic malignant
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and pre-malignant conditions with a low rate of adverse short-term outcomes, including re-
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operation, surgical site infection, readmission, ICU admission, blood transfusion, conversion to
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laparotomy and multi-port laparoscopy and venous thromboembolism.6-11 In a retrospective
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review of 102 patients undergoing SPL for benign and malignant conditions by Jennings et al.,
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similar low rates of adverse outcomes including intra-operative injury, surgical site infection,
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blood transfusion and readmission were noted.9 Similarly, Gunderson et al. identified a low rate
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of umbilical cellulitis of 5.2%.
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In our study, the overall rate of incisional hernia of 5.5% with a median time to diagnosis of
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570.2 days. Within gynecologic oncology specifically, there is a paucity of data regarding
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incisional hernia incidence and timing with previous studies limited by small numbers of patients
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and short follow-up duration.5-10 While the hernia rate in this study is higher than previously
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reported, the longer period of follow-up suggests that previous studies may have underestimated
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the risk of hernia development. Additionally, we identified that hernia rates are higher amongst
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patients with increasing medical comorbidities given that patients with ASA score of III or IV,
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diabetes mellitus, obesity and hypertension were predictors for hernia development. For patients
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with diabetes mellitus specifically, the rate of hernia free survival was 77.0% at 3 years.
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Similarly, hernia free survival was 84.9% among those with a BMI greater than 30 at 3 years.
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These findings are consistent with data for SPL within the general surgery literature where
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incisional hernia rates as high as 33% at 3.5 years have been reported with increasing age and
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BMI as significant predictors for hernia development.13-16 Interestingly, these non-modifiable
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and patient-specific variables were the only predictors for hernia development in our analysis,
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and may also help surgeons in choosing the optimal surgical technique for a specific patient.
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While data comparing use of delayed absorbable with extremely delayed absorbable or
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permanent suture for umbilical incision closure after single port laparoscopy is not currently
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available, this may be considered in patients at highest risk for hernia development, such as those
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who are obese. These rates are important for patient counseling when discussing surgical
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approaches as part of pre-operative counseling. Within gynecologic and general surgery
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literature, traditional laparoscopy and robotic assisted procedures, umbilical hernia rates of up to
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3.1% have been reported.18-22 It is understood that a variety of factors increase the risk for hernia
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development after conventional laparoscopy including increasing size of fascial incision, obesity
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and patient comorbidities leading to connective tissue weakness which is comparable to single
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port laparoscopy.18-22 Future studies are needed to delineate surgical techniques and materials to
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reduce hernia rate amongst these patients and to identify long-term patient satisfaction outcomes
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with this surgical approach.
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Limitations of our study include the retrospective nature of the study and biases inherent to
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studies with such a design. After patients underwent a single port laparoscopy procedure, follow
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up visits were not standardized. For example, physical examinations could be performed by a
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variety of providers and abdominal imaging was not required for inclusion in the final analysis.
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Therefore, it is possible that the rate of hernia may be underestimated, especially in patients
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where detectability of hernia may be decreased, such as those who are morbidly obese. Although
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this study was performed at a single institution referral center for gynecologic oncology, the
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variation of procedures included demonstrates the flexibility of this surgical platform for the
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operative management of a variety of malignant and pre-malignant gynecologic conditions. The
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range of procedures performed provides a realistic reflection of operative practices for
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gynecologic oncologists and helps with extrapolating the data to other centers or locations.
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Strengths of this study include this being the largest known series of this minimally invasive
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approach in an experienced center to treat gynecologic cancer and precancerous conditions with
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favorable clinical outcomes and a mean follow-up duration that exceeds previously published
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studies.
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Single port laparoscopy offers an additional way for surgeons to perform minimally invasive
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surgery for a variety of indications. In this study, single port laparoscopy performed by
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experienced gynecologic surgeons lead to a low rate of adverse outcomes and will continue to be
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offered to patients as a safe and effective alternative to traditional laparoscopy for treatment of
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benign and malignant gynecologic conditions, where feasible. In conclusion, this study provides
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further evidence that single port laparoscopy is safe and feasible for the surgical management of
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many pre-malignant and malignant conditions within gynecologic oncology with a low rate of
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short-term adverse outcomes. While the overall rate of incisional hernia was low, it was
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significantly higher than previously reported suggesting that previous studies may have
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underestimated the risk of hernia. Additionally, patients with complex medical comorbidities are
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at higher risk of hernia development. Future research is needed to determine techniques for
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hernia reduction with SPL.
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Acknowledgements: James Bena, MS of the Cleveland Clinic Quantitative Health Sciences
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Department for assistance with statistics.
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References
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7. Escobar PF, Starks DC, Fader AN, Barber M, Rojas-Espalliat L. Single-port risk-reducing
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salpingo-oophorectomy with and without hysterectomy: Surgical outcomes and learning curve
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analysis. Gynecol Oncol. 2010 Oct;119(1):43-7.: surgical outcomes and learning curve analysis.
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Gynecol.Oncol. 2010 Oct;119:43-47.
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8. Fagotti A, Boruta DM,2nd, Scambia G, Fanfani F, Paglia A, Escobar PF. First 100 early
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endometrial cancer cases treated with laparoendoscopic single-site surgery: A multicentric
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retrospective study. Am J Obstet Gynecol. 2012 Apr;206(4):353.e1,353.e6.
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9. Jennings AJ, Spencer RJ, Hanks L, Barroilhet L, Kushner D, Rose S, et al. The feasibility and
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safety of adopting single-incision laparoscopic surgery into gynecologic oncology practice. J
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Minim Invasive Gynecol. 2016 Mar-Apr;23(3):358-63.Oncology Practice. J.Minim Invasive
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Gynecol. 2016 Mar-Apr;23:358-363.
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10. Tergas AI, Fader AN. Laparoendoscopic single-site surgery (LESS) radical hysterectomy for
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the treatment of early stage cervical cancer. Gynecol Oncol. 2013 Apr;129(1):241-3.
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11. Boruta DM, Fagotti A, Bradford LS, Escobar PF, Scambia G, Kushnir CL, et al.
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Laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy: Initial multi-
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institutional experience for treatment of invasive cervical cancer. J Minim Invasive Gynecol.
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2014 May-Jun;21(3):394-8.
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12. Gunderson CC, Knight J, Ybanez-Morano J, Ritter C, Escobar PF, Ibeanu O. The risk of
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umbilical hernia and other complications with laparoendoscopic single-site surgery. J Minim
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Invasive Gynecol. 2012 Jan-Feb; 19(1):40-5.
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13. Agaba EA, Rainville H, Ikedilo O, Vemulapali P. Incidence of port-site incisional hernia
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after single-incision laparoscopic surgery. JSLS. 2014 Apr-Jun;18(2):204-10.
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14. Antoniou SA, Morales-Conde S, Antoniou GA, Granderath FA, Berrevoet F, Muysoms FE,
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et al. Single-incision laparoscopic surgery through the umbilicus is associated with a higher
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incidence of trocar-site hernia than conventional laparoscopy: A meta-analysis of randomized
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controlled trials. Hernia. 2016 Feb;20(1):1-10.
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15. Buckley FP,3rd, Vassaur HE, Jupiter DC, Crosby JH, Wheeless CJ, Vassaur JL. Influencing
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factors for port-site hernias after single-incision laparoscopy. Hernia. 2016 Oct;20(5):729-33.
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16. Julliard O, Hauters P, Possoz J, Malvaux P, Landenne J, Gherardi D. Incisional hernia after
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single-incision laparoscopic cholecystectomy: Incidence and predictive factors. Surg Endosc.
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2016 Oct;30(10):4539-43.
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17. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data
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capture (REDCap)--a metadata-driven methodology and workflow process for providing
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translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81.
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18 Bowrey DJ, Blom D, Crookes PF, Bremner CG, Johansson JL, Lord RV, et al. Risk factors
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and the prevalence of trocar site herniation after laparoscopic fundoplication. Surg.Endosc. 2001
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Jul;15:663-666.
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19. Coda A, Bossotti M, Ferri F, Mattio R, Ramellini G, Poma A, et al. Incisional hernia and
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fascial defect following laparoscopic surgery. Surg.Laparosc.Endosc.Percutan.Tech. 1999
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Oct;9:348-352.
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20. Crist DW, Gadacz TR. Complications of laparoscopic surgery. Surg.Clin.North Am. 1993
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Apr;73:265-289.
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21. Kadar N, Reich H, Liu CY, Manko GF, Gimpelson R. Incisional hernias after major
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laparoscopic gynecologic procedures. Am.J.Obstet.Gynecol. 1993 May;168:1493-1495.
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22. Montz FJ, Holschneider CH, Munro M. Incisional Hernia Following Laparoscopy: A Survey
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Table 1: Demographic data for patients undergoing Single Port Laparoscopy
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24(2.7) 459(50.8) 404(44.7) 16(1.8) 144(15.9) 11(1.2) 88(9.7) 112(12.3) 12(10.9) 98(89.1) 49(5.4) 81(8.9) 5(0.55)
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793(87.9) 4(0.44) 86(9.5) 9(1.00) 10(1.1) 29.6±7.5
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Total (N=908) 55.7±13.0
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Factor Age (years) Race Caucasian Hispanic African American Asian Pacific Islander Other BMI (kg/m2) ASA I II III IV Smoking at the Time of Surgery Neoadjuvant chemotherapy Adjuvant chemotherapy Radiation Before surgery After surgery Pelvic RT Vaginal Brachytherapy Extended field RT Medical comorbidities Diabetes Mellitus HTN Obesity Pulmonary disease Immunosuppression Coronary artery disease Peripheral vascular disease Hormone replacement In the past Until surgery Never Indication for Surgery Adnexal mass Endometrial hyperplasia or cancer Cervical dysplasia or cancer Molar pregnancy or GTN Ovarian, fallopian tube or peritoneal carcinoma Risk reduction surgery Personal history of breast cancer
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374 375
139(15.3) 390(43.0) 338(37.2) 107(11.8) 4(0.44) 85(9.4) 29(3.2) 360(39.7) 138(15.2) 408(45.0) 335(36.9) 339(37.3) 40(4.4) 2(0.22) 49(5.4) 128(14.1) 126(13.9)
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Prior abdominal surgeries
1.08±1.3
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Statistics presented as Mean ± SD or N (column %). ASA, American society of Anesthesiologists; BMI, body mass index; RT, radiation therapy; HTN, hypertension; GTN, gestational trophoblastic neoplasia
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376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402
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Table 2: Intra-operative data for patients undergoing Single Port Laparoscopy
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569 (62.7) 782 (86.1) 781 (86.0) 746 (82.2) 729 (80.3) 126 (13.9) 67 (7.4) 79 (8.7) 44 (4.8) 16 (1.8) 5 (0.6) 5 (0.6) 3 (0.3) 36 (3.9) 121.8±69.1 65.0±114.1 13(1.4) 3 (0.3) 2 (0.2) 5 (0.5) 1 (0.1) 35 (3.9) 6 (0.7) 29 (3.2) 4(0.44) 45 (5.0)
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405 406 407 408
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Factor Procedure Hysterectomy Right salpingectomy Left salpingectomy Right oophorectomy Left oophorectomy Pelvic lymphadenectomy Para-aortic lymphadenectomy Omenectomy Peritoneal biopsies Appendectomy Small bowel surgery Large bowel surgery Trachelectomy Sentinel lymph node mapping Operative Time (minutes) EBL (mL) Intraoperative injury Bowel Bladder Ureters Major vascular injury Conversion Multiport laparoscopy Laparotomy Intraoperative transfusion Hand assist
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Statistics presented as Mean ± SD or N (column %). EBL, estimated blood loss
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Total (N=908) 1 (0.1) 4 (0.4) 7 (0.8) 37 (4.0) 16 (1.7) 26 (2.8) 2 (0.2) 1 (0.1)
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Factor Re-operation within in <48 hours Unplanned ICU admission in 30 days Postoperative transfusion in 30 days Postoperative fever within 30 days Urinary retention within 30 days UTI within 30 days of surgery DVT within 30 days of surgery PE within 30 days of surgery Delayed injury diagnosed within 30 days of surgery Bowel Bladder Ureter Incisional Cellulitis within 30 days of surgery Deep wound infection within 30 days of surgery Vaginal cuff dehiscence within 30 days of surgery Readmission within 30 days Incisional hernia Time to hernia development (days)
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Table 3: Short term postoperative outcomes and hernia outcome in patients undergoing Single Port Laparoscopy
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414 415 416
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10 (1.1)
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Post-operative outcomes presented as N (%). Time to hernia development is presented as median time to hernia development in days (+/- range). ICU, intensive care unit; UTI, urinary tract infection; DVT, deep venous thrombosis; PE, pulmonary embolism
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1 (0.1) 1 (0.1) 1 (0.1) 32 (3.5)
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Table 4. Hernia-free survival for patients undergoing Single Port Laparoscopy Variable 1 Year 2 Years 3 Years Hazard Ratio P(95% CI) value Overall 95.3 (93.6, 91.3 (88.8, 90.5 (87.8, 97.0) 93.8) 93.2) ASA I/II 95.3 (93.0, 93.7 (90.7, 93.7 (90.7, 1.00 0.041 97.8) 96.8) 96.8) ASA III/IV 95.3 (92.9, 88.8 (84.9, 87.2 (82.8, 1.81 (1.02, 3.19) . 97.7) 93.0) 91.9) Current Smoking 96.0 (92.2, 88.9 (81.6, 88.9 (81.6, 1.02 (0.48, 2.17) 0.95 99.9) 96.8) 96.8) 0.77 Chemotherapy 94.8 (89.9, 90.5 (83.3, 90.5 (83.3, 1.14 (0.47, 2.77) 99.9) 98.3) 98.3) 0.21 Pelvic radiation 93.6 (88.8, 88.0 (80.5, 84.4 (74.7, 1.58 (0.78, 3.23) 98.7) 96.3) 95.4) Chemotherapy + Radiation 95.7 (89.9, 91.8 (83.0, 91.8 (83.0, 1.00 (0.36, 2.75) 0.99 100) 100) 100) Diabetes Mellitus 92.2 (87.1, 79.3 (70.2, 77.0 (67.3, 3.60 (2.02, 6.41) <0.001 97.5) 89.5) 88.1) HTN 94.2 (91.4, 88.8 (84.7, 87.1 (82.5, 1.81 (1.02, 3.20) 0.04 97.0) 93.1) 92.0) Obesity 91.8 (88.4, 87.1 (82.5, 84.9 (79.6, 3.23 (1.74, 5.99) <0.001 95.3) 91.8) 90.5) 0.71 Pulmonary Disease 98.7 (96.3, 95.6 (90.8, 90.1 (81.6, 0.74 (0.30, 1.86) 100) 100) 99.4) Coronary Artery Disease 93.2 (87.0, 91.1 (83.9, 88.1 (79.4, 1.18 (0.50, 2.75) 0.12 99.9) 98.9) 97.9) Race (Not Caucasian) 98.7 (96.2, 96.4 (91.4, 96.4 (91.4, 1.00 0.13 100) 100) 100) Race (Caucasian) 94.9 (93.0, 90.6 (87.9, 89.8 (86.8, 3.01 (0.73, . 96.8) 93.4) 92.8) 12.41) Adenexal/Ovarian Mass 93.9 (90.5, 92.3 (88.2, 92.3 (88.2, 0.79 (0.42, 1.52) 0.48 97.5) 96.5) 96.5) Endometrial Cancer 96.0 (93.7, 89.9 (85.9, 88.1 (83.6, 1.50 (0.84, 2.69) 0.65 98.4) 94.0) 92.9) Ovarian/Fallopian Tube 94.9 (88.2, 87.0 (75.5, 87.0 (75.5, 1.27 (0.46, 3.48) 0.15 Carcinoma 100) 100) 100) Risk Reduction Surgery 100 (100, 97.4 (92.6, 97.4 (92.6, 0.23 (0.03, 1.69) 0.96 100) 100) 100)
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Hysterectomy
3 Years
94.1 (88.7, 99.9) 96.7 (90.5, 100) 95.7 (93.8, 97.7) 93.4 (90.0, 96.9) 92.8 (87.5, 98.6) 94.3 (89.1, 99.9)
90.8 (84.1, 98.1) 87.9 (75.7, 100) 90.3 (87.1, 93.7) 90.5 (86.2, 95.0) 89.6 (82.9, 96.8) 85.2 (75.9, 95.8)
90.8 (84.1, 98.1) 87.9 (75.7, 100) 89.2 (85.6, 92.9) 89.6 (84.9, 94.4) 86.8 (78.6, 95.9) 85.2 (75.9, 95.8)
Hazard Ratio (95% CI) 1.02 (0.43, 2.44)
Pvalue 0.64
1.32 (0.42, 4.17)
0.27
1.45 (0.75, 2.78)
0.65
1.63 (0.82, 3.25)
.
1.98 (0.86, 4.57)
.
2.23 (0.88, 5.62)
425
Hernia free survival presented as N, indicating the frequency of patients not diagnosed with a
427
hernia at each time point (interquartile range). Hazard ratios are presented along with 95%
428
confidence interval and P values with <0.05 considered significant.
429
ASA, American Society of Anesthesiologists; HTN, hypertension.
433 434 435 436
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432
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431
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426
430
.
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Prior Abdominal Surgeries
2 Years
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Personal History of Breast Cancer Hand Assist
1 Year
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Variable
437 438 439
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440 441
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Figure Legend
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Figure 1: Multi-instrument single incision platform demonstrating a typical instrument set up.
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Table 1: Demographic data for patients undergoing Single Port Laparoscopy
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Table 2: Intraoperative data for patients undergoing Single Port Laparoscopy
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Table 3: Short term postoperative outcomes and hernia outcome in patients undergoing Single
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Port Laparoscopy
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Table 4. Hernia-free survival for patients undergoing Single Port Laparoscopy
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450
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S0002-9378(17)30744-5
DOI:
10.1016/j.ajog.2017.06.008
Reference:
YMOB 11725
To appear in:
American Journal of Obstetrics and Gynecology
Received Date: 16 December 2016 Revised Date:
31 May 2017
Accepted Date: 6 June 2017
Please cite this article as: Moulton L, Jernigan AM, Carr C, Freeman L, Escobar PF, Michener CM, Single Port Laparoscopy in Gynecologic Oncology: Seven Years of Experience at a Single Institution, American Journal of Obstetrics and Gynecology (2017), doi: 10.1016/j.ajog.2017.06.008. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Single Port Laparoscopy in Gynecologic Oncology: Seven Years of Experience at a Single
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Institution
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Laura Moulton, DO, MS1*; Amelia M. Jernigan, MD2; Caitlin Carr, MD1; Ms. Lindsey
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Freeman3, BS; Pedro F. Escobar, MD4, Chad M. Michener, MD5
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Avenue, Cleveland, OH, USA, 44195.
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Obstetrics, Gynecology and Women’s Health Institute, Cleveland Clinic, 9500
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Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Louisiana State
University Healthcare Network, New Orleans, LA, USA
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Case Western Reserve School of Medicine, Cleveland, OH USA
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Instituto Gyneco-Oncólogico, San Juan 00926, PR
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Division of Gynecologic Oncology, Obstetrics, Gynecology and Women’s Health Institute,
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Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH, USA, 44195.
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* Corresponding Author: Laura J. Moulton, DO, MS; Email: [email protected], Phone: (216)-
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212-2854; Fax: (216)-445-6325
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No financial support obtained for this research.
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The authors report no conflicts of interest.
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These findings were presented at the 43rd Annual Scientific Meeting of the Society of
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Gynecologic Surgeons in San Antonio, TX, March 26-29th.
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Manuscript word count: 2092, Abstract word count: 399, Tables: 4, Figures: 1; Print issue figure:
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Table 3
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Condensation: Single port laparoscopy is associated with low short-term adverse outcomes in
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gynecologic oncology. Risk of incisional hernia may have been previously underestimated.
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Short Title: Single port laparoscopy in gynecologic oncology
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Abstract
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Background: Single port laparoscopy has gained popularity within minimally invasive
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gynecologic surgery for its feasibility, cosmetic outcomes and safety. However, within
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gynecologic oncology, there is limited data regarding short-term adverse outcomes and long term
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hernia risk in patients undergoing single port laparoscopic surgery.
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Objective: To describe short-term outcomes and hernia rates in patients after single port
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laparoscopy in a gynecologic oncology practice.
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Methods: A retrospective, single institution study was performed for patients who underwent
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single port laparoscopy from 2009-2015. Univariate analysis was performed with chi-square tests
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and t-tests; Kaplan Meier and Cox proportional hazards determined time to hernia development.
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Results: 898 patients underwent 908 surgeries with a median follow-up of 37.2 months. The
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mean age and body mass index were 55.7 years and 29.6 kg/m2, respectively. The majority were
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Caucasian (87.9%) and American Society of Anesthesiologists class II/III (95.5%). The majority
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of patients underwent surgery for adnexal masses (36.9%) and endometrial hyperplasia/cancer
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(37.3%). Most women underwent hysterectomy (62.7%) and removal of one or both fallopian
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tubes and/or ovaries (86%). Rate of adverse outcomes within 30 days, including reoperation
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(0.1%), intraoperative injury (1.4%), intensive care unit admission (0.4%), venous
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thromboembolism (0.3%) and blood transfusion, were low (0.8%). The rate of urinary tract
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infection was 2.8%; higher body mass index (p=0.02), longer operative time (p=0.02), smoking
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(p=0.01), hysterectomy (p=0.01), and cystoscopy (p=0.02) increased risk. The rate of incisional
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cellulitis was 3.5%. Increased estimated blood loss (p=0.03) and endometrial cancer (p=0.02)
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were independent predictors of incisional cellulitis. Rate for surgical readmissions was 3.4%;
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higher estimated blood loss (p=0.03), longer operative time (p=0.02), chemotherapy alone
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(p=0.03) and combined chemotherapy and radiation (p<0.05) increased risk. Rate of incisional
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hernia rate was 5.5% (n=50) with a mean occurrence at 570.2 ± 553.3 days. Higher American
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society of Anesthesiologists class (p=0.04), diabetes (p<0.001), hypertension (p=0.043),
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increasing age (p=0.017; HR 1.03) and body mass index (p<0.001; HR 1.08) were independent
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predictors for incisional hernia development. Previous abdominal surgeries (p=0.24) and hand-
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assist (p=0.64) were not associated with increased risk for incisional hernia. Patients with
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American society of Anesthesiologists class III/IV had a 3-year hernia rate of 12.8% (HR 1.81).
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Patients with diabetes mellitus had a 3-year hernia rate of 23.0% (HR 3.60).
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Conclusions: In this large cohort of patients undergoing single port laparoscopy, the incidence of
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short-term adverse outcomes is low. While the rate of incisional hernia was 5.5%, incidence
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reached 23.0% at three years in high-risk groups. Previous studies with short follow up duration
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may underestimate the risk of hernia, especially in patients with significant comorbidities.
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Key words: Single port laparoscopy, minimally invasive surgery, single incision laparoscopy,
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gynecologic oncology, laparoendoscopic single site surgery, adverse outcomes, incisional hernia
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Introduction
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Laparoscopic surgery has become a mainstay within gynecology for completion of many
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procedures for benign and malignant indications. Minimally invasive surgery is associated with
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improved patient quality of life, reduced perioperative morbidity, shorter hospitalization and
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improved recovery time compared to laparotomy.1,2 More recently gynecologists have applied
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single port laparoscopic (SPL) surgery, also known as single-incision laparoscopic surgery
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(SILS) and laparoendoscopic single site surgery (LESS) to common gynecologic problems,
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which allows for a single incision most commonly through the umbilicus.3,4 After it was first
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reported within gynecologic oncology in 2009 by Fader et al. growing data has demonstrated that
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SPL is a feasible and safe minimally invasive platform for the treatment of many gynecologic
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malignancies.5 However, the current literature is limited by small sample sizes of patients or
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short duration of follow-up which precludes making statements regarding long-term outcomes
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and rate of incisional hernia.5-11
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Within gynecologic oncology specifically, there is limited data regarding short-term adverse
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outcomes and long-term hernia risk in patients having SPL. Gunderson et al. performed a
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retrospective review of 211 patients undergoing SPL for benign or malignant gynecologic
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conditions, and 2.4% developed an umbilical hernia at a median duration of 16 months.12 In a
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similar study by Jennings et al., the rate of an incisional hernia was reported at 1.8% within 30
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days, with limited data for the risk at later time points.9 Among other surgical specialties
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performing SPL, incisional hernia rates as high as 33% at 3.5 years have been reported, with
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increasing age and BMI as significant predictors for hernia development.13-16 The objective of
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this study is to describe short-term outcomes and long-term incisional hernia rates in patients
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after single port laparoscopy in a gynecologic oncology practice.
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Methods
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An IRB approved retrospective, single institution study was performed for patients who
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underwent SPL from 2009-2015 with the gynecologic oncology division at Cleveland Clinic
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Foundation. All patients who underwent SPL were identified and included in the study without
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exclusions. No robotic SPL procedures were included in the analysis.
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Three gynecologic oncologists performed the surgeries. Patients underwent surgery through a
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single vertical umbilical incision using the open Hasson approach for abdominal entry. After
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abdominal entry was obtained, a multi-instrument access port was used (GelPOINT and
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GelPORT; Applied Medical, Rancho Santa Margarita, CA) (Figure 1). At the end of each
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operation, the fascia was identified and closed with a delayed absorbable suture (Vicryl, ethicon,
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Cincinnati, OH or Polysorb, Medtronic, minneappolis, MN). Permanent suture was utilized for
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patients with umbilical hernia on abdominal entry or at the surgeons discretion for patients felt to
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be at risk for hernia such as those requiring chemotherapy.
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All data was collected and stored securely within a RedCAP database.17 Data collection included
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patient age, BMI, race, medical comorbidities, surgical history and surgical indication. Operative
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variables included length of surgery, estimated blood loss, length of hospital stay, conversion to
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multi-port laparoscopy or laparotomy and hand-assist. Surgical time was defined as time from
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skin incision to closure. Intraoperative complications were defined as injury to bowel, bladder,
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ureters, nervous or vascular structures. Data was collected for postoperative complications which
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included return to OR in less than 48 hours and unplanned ICU admission, blood transfusion,
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fevers, urinary retention, urinary tract infection, venous thromboembolism (DVT or PE), delayed
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bowel, ureteral or bladder injury, incisional cellulitis, deep wound infection, vaginal cuff
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dehiscence or readmission. Distant outcomes were collected regarding incisional hernia
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development and timing and disease recurrence. Incisional hernia was defined as any hernia that
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was detected clinically during post-operative surveillance with gynecologic oncology, benign
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gynecology, primary care and surgical subspecialties within our hospital electronic medical
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record after surgery either via physical exam or radiographically.
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For statistical analysis, categorical factors were summarized using frequencies and percentages,
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while continuous measures summaries used means and standard deviations. To evaluate risk
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factors for early outcomes, Pearson chi-square tests and two sample t-tests were used, while
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Kaplan Meier estimates and Cox proportional hazards were used to evaluate differences in time
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to hernia development. The variables chosen as potential predictors of hernia-free survival were
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derived in two ways. First, from prior studies that demonstrated possible predictors for hernia
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development after single port laparoscopy in gynecology and general surgery. Secondly,
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variables were derived from literature on hernias for traditional multi-port laparoscopy in
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gynecology and other surgical subspecialties. Risk estimates were provided as odds ratios with
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95% confidence limits for early outcomes, and hazard ratios with 95% confidence limits for time
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to hernia development. Given the small event rate, only factors with at least 40 patients in each
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level were considered as potential predictors. Analysis was performed using SAS software
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(version 9.4; Cary, NC).
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Results
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In total, 908 SPL surgeries were performed in 898 patients and all cases were included in the
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analysis with a median follow-up for the entire cohort of 37.2 months. Ten patients underwent
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two surgeries. Indications for proceeding with two surgeries included surgical staging after
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malignancy identified on risk reducing surgery (n=3), development of contralateral ovarian mass
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(n=3), surgery for recurrent disease (n=2) and completion hysterectomy for cervical carcinoma
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(n=1). Table 1 includes preoperative patient characteristics. The mean age and BMI were
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55.7±13.0 years old and 29.6±7.5 kg/m2, respectively. The majority of patients were Caucasian
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(n=793, 87.9%) or African American (n=86; 9.5%). 12.3% (n=112) had undergone radiation.
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Additionally, eleven patients (1.2%) had received neoadjuvant chemotherapy and 88 (9.7%)
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received adjuvant chemotherapy. Of the 908 surgeries performed, 36.9% (n=335) were
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performed for adnexal masses, 37.3% (n=339) for endometrial hyperplasia or cancer, 14.1%
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(128) for risk reduction for increased risk of breast and ovarian cancer, 13.9% (n=126) for
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history of breast cancer, 4.4% (n=40) for cervical dysplasia or cancer, 5.4% (n=49) for ovarian,
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fallopian tube or peritoneal carcinoma and 0.2 (n=2) for molar pregnancy or gestational
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trophoblastic neoplasia.
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Table 2 includes intraoperative data. For procedures performed, 62.7% (n=569) underwent
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hysterectomy, 82.2% (n=746) right oophorectomy and 80.3% (n=729) left oophorectomy. 126
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patients (13.9%) underwent pelvic lymphadenectomy and 67 patients (7.4%) para-aortic
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lymphadenectomy. Hand-assist surgery was performed in 45 patients (5.0%) with a total
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conversion rate of 3.9% (n=35), with 3.2% of cases converted to laparotomy (n=29) and 0.7%
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(n=6) converted to multi-port laparoscopy. Malignancy requiring surgical staging (n=16; 55.2%,
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dense adhesive disease (n=8; 27.6%), repair of intra-operative injury (n=4; 13.8%) and removal
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of specimen (n=4; 13.8%) were the leading reasons for conversion to laparotomy.
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Dense adhesions (n=3; 50%), malignancy with need for staging (n=1; 16,7%) and repair of intra-
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operative injury (n=1; 16.7%) were the reasons for conversion to multi-port laparoscopy. The
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mean operative time was 121.8±69.1 minutes with mean estimated blood loss of 65.0±114.1 mL.
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Table 3 reports postoperative outcomes, including short-term adverse events and hernia outcome.
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Of 908 surgeries, one patient (0.1%) underwent reoperation within 48 hours, four patients (0.4%)
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had unplanned ICU admission and seven patients (0.8%) received blood transfusion within 30
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days. Within 30 days of surgery, 4.0% (n=37) of patients developed fever >100.4F, 1.7% (n=16)
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had urinary retention, 2.8% (n=26) developed UTI, 0.2% (n=2) developed deep venous
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thrombosis and 0.1% (n=1) developed pulmonary embolism. Three patients had delayed injury
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noted within 30 days of surgery with one patient each developing bowel, bladder or ureteral
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injury (0.1%; n=1), respectively. Within 30 days of surgery, the rate of surgical site infection
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was 4.5% (n=41). 32 patients (3.5%) developed incisional cellulitis, ten patients (1.1%)
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developed a deep wound infection including one patient with concurrent cellulitis. One patient
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(0.1%) had a vaginal cuff dehiscence. Urinary retention within 30 days of surgery was more
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common among patients of increasing age (mean age of 68.6 vs. 55.5 years; p<0.001) and
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patients receiving pelvic radiation (4.5% vs. 1.4%; p=0.038) and adjuvant/neoadjuvant
197
chemotherapy (6.4% vs. 1.2%; p=0.004). Postoperative UTI within 30 days of surgery was
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increased among patients with increased BMI (33.0 vs. 29.6; p=0.02), longer operative time
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(152.0 vs. 120.9 minutes; p=0.02), tobacco use (p=0.01) and hysterectomy (p=0.01) and
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cystoscopy (p=0.02). Predictors for development of incisional cellulitis within 30 days of
201
surgery were higher estimated blood loss (110.0 vs. 63.5cc; p=0.03) and surgery for endometrial
202
cancer (p=0.02). Longer operative time (150.1 vs. 120.8; p=0.02), higher estimated blood loss
203
(107.3 vs. 63.5; p=0.03), chemotherapy (p=0.03) and chemotherapy and radiation (p<0.05) were
204
associated with increased likelihood of readmission within 30 days.
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The rate of incisional hernia was 5.5% (n=50) with a mean time to hernia development of
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570.2±553.3 days. The total range of time to hernia development was 93 to 1694 days. Among
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patients who developed an incisional hernia, the rate of previous umbilical hernia repair surgery
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was 6.0% (n=3). Significant predictors for hernia formation were increasing age (HR 1.03; 95%
209
CI 1.00-1.05; p=0.001) and higher BMI (HR 1.08; 95% CI 1.05-1.11; p<0.001). Among those
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who developed a hernia, rate of post-operative cellulitis was low (n=1; 2.0%).
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Table 4 describes hernia free survival for patients included in the final analysis. For all patients,
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the overall hernia free survival was 95.3% (93.6,97.0), 91.3% (88.8,93.8) and 90.5% (87.8,93.2)
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at 1, 2 and 3 years respectively. Patients with ASA class III/IV had a significantly lower 3-year
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hernia free survival compared to patients classified as ASA I/II (87.2% vs. 93.7%; 95% CI
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1.02,3.19; HR 1.81; p=0.04). Amongst patients with diabetes mellitus, the hernia free survival
216
was 92.2% (87.1, 97.5), 79.3% (70.2, 89.5) and 77.0% (67.3, 88.1) at 1, 2 and 3 years
217
respectively (p<0.001). Similarly, in patients with hypertension the hernia free survival was
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94.2% (91.4, 97.0), 88.8% (84.7, 93.1) and 87.1% (82.5, 92.0) at 1, 2 and 3 years respectively
219
(p=0.04). Patients with obesity, defined as BMI >30, had significantly higher rate of a hernia
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developed with 1, 2 and 3 years hernia free survival of 91.8% (88.4, 95.3), 87.1% (82.5, 91.8)
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and 84.9% (79.6, 90.5), respectively (p<0.001). There was no difference in hernia free survival
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for patients who received chemotherapy alone (HR 1.14; 95% CI 0.47, 2.77), radiation alone
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(HR 1.58; 95% CI 0.78, 3.23), combined chemotherapy and radiation (HR 1.00; 95% CI 0.36,
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2.75) or those who used tobacco products (95% CI 0.48,2.17; HR 1.02).
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Of the 50 patients with post-operative umbilical incisional hernias, 28 patients (56%) underwent
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corrective surgery due to bothersome symptoms, including abdominal pain or bulge sensation.
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Only one procedure (2%) was performed in an emergent manner for an incarcerated hernia. Of
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the 28 surgeries performed, the majority were performed by general surgery (n=27; 96.4%).
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Discussion
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The utility of minimally invasive surgery in the management of gynecologic malignancies is well
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established.1,2 As surgical practices are continually evolving, techniques allowing for safe,
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efficient and cost-effective operations with favorable recovery time are necessary. Since our
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institution first described usage of SPL in gynecologic oncology in 2009, this technique has been
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successfully utilized to perform a multitude of procedures with favorable surgical and cosmetic
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outcomes in women with gynecologic malignancy.5-11 After seven years of experience with this
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surgical technique, this study reports on the largest series of patients undergoing single port
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laparoscopy in gynecologic oncology. Our findings add to the growing body of literature that
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SPL is a safe and feasible method to perform a variety of procedures for gynecologic malignant
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and pre-malignant conditions with a low rate of adverse short-term outcomes, including re-
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operation, surgical site infection, readmission, ICU admission, blood transfusion, conversion to
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laparotomy and multi-port laparoscopy and venous thromboembolism.6-11 In a retrospective
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review of 102 patients undergoing SPL for benign and malignant conditions by Jennings et al.,
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similar low rates of adverse outcomes including intra-operative injury, surgical site infection,
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blood transfusion and readmission were noted.9 Similarly, Gunderson et al. identified a low rate
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of umbilical cellulitis of 5.2%.
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In our study, the overall rate of incisional hernia of 5.5% with a median time to diagnosis of
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570.2 days. Within gynecologic oncology specifically, there is a paucity of data regarding
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incisional hernia incidence and timing with previous studies limited by small numbers of patients
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and short follow-up duration.5-10 While the hernia rate in this study is higher than previously
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reported, the longer period of follow-up suggests that previous studies may have underestimated
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the risk of hernia development. Additionally, we identified that hernia rates are higher amongst
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patients with increasing medical comorbidities given that patients with ASA score of III or IV,
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diabetes mellitus, obesity and hypertension were predictors for hernia development. For patients
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with diabetes mellitus specifically, the rate of hernia free survival was 77.0% at 3 years.
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Similarly, hernia free survival was 84.9% among those with a BMI greater than 30 at 3 years.
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These findings are consistent with data for SPL within the general surgery literature where
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incisional hernia rates as high as 33% at 3.5 years have been reported with increasing age and
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BMI as significant predictors for hernia development.13-16 Interestingly, these non-modifiable
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and patient-specific variables were the only predictors for hernia development in our analysis,
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and may also help surgeons in choosing the optimal surgical technique for a specific patient.
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While data comparing use of delayed absorbable with extremely delayed absorbable or
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permanent suture for umbilical incision closure after single port laparoscopy is not currently
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available, this may be considered in patients at highest risk for hernia development, such as those
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who are obese. These rates are important for patient counseling when discussing surgical
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approaches as part of pre-operative counseling. Within gynecologic and general surgery
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literature, traditional laparoscopy and robotic assisted procedures, umbilical hernia rates of up to
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3.1% have been reported.18-22 It is understood that a variety of factors increase the risk for hernia
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development after conventional laparoscopy including increasing size of fascial incision, obesity
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and patient comorbidities leading to connective tissue weakness which is comparable to single
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port laparoscopy.18-22 Future studies are needed to delineate surgical techniques and materials to
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reduce hernia rate amongst these patients and to identify long-term patient satisfaction outcomes
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with this surgical approach.
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Limitations of our study include the retrospective nature of the study and biases inherent to
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studies with such a design. After patients underwent a single port laparoscopy procedure, follow
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up visits were not standardized. For example, physical examinations could be performed by a
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variety of providers and abdominal imaging was not required for inclusion in the final analysis.
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Therefore, it is possible that the rate of hernia may be underestimated, especially in patients
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where detectability of hernia may be decreased, such as those who are morbidly obese. Although
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this study was performed at a single institution referral center for gynecologic oncology, the
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variation of procedures included demonstrates the flexibility of this surgical platform for the
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operative management of a variety of malignant and pre-malignant gynecologic conditions. The
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range of procedures performed provides a realistic reflection of operative practices for
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gynecologic oncologists and helps with extrapolating the data to other centers or locations.
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Strengths of this study include this being the largest known series of this minimally invasive
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approach in an experienced center to treat gynecologic cancer and precancerous conditions with
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favorable clinical outcomes and a mean follow-up duration that exceeds previously published
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studies.
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Single port laparoscopy offers an additional way for surgeons to perform minimally invasive
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surgery for a variety of indications. In this study, single port laparoscopy performed by
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experienced gynecologic surgeons lead to a low rate of adverse outcomes and will continue to be
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offered to patients as a safe and effective alternative to traditional laparoscopy for treatment of
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benign and malignant gynecologic conditions, where feasible. In conclusion, this study provides
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further evidence that single port laparoscopy is safe and feasible for the surgical management of
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many pre-malignant and malignant conditions within gynecologic oncology with a low rate of
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short-term adverse outcomes. While the overall rate of incisional hernia was low, it was
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significantly higher than previously reported suggesting that previous studies may have
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underestimated the risk of hernia. Additionally, patients with complex medical comorbidities are
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at higher risk of hernia development. Future research is needed to determine techniques for
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hernia reduction with SPL.
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Acknowledgements: James Bena, MS of the Cleveland Clinic Quantitative Health Sciences
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Department for assistance with statistics.
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References
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1. Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, et al. Surgical approach to
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hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug
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2. Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, et al.
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3. Pontis A, Sedda F, Mereu L, Podda M, Melis GB, Pisanu A, et al. Review and meta-analysis
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6. Escobar PF, Fader AN, Rasool N, Espalliat LR. Single-port laparoscopic pelvic and para-
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7. Escobar PF, Starks DC, Fader AN, Barber M, Rojas-Espalliat L. Single-port risk-reducing
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8. Fagotti A, Boruta DM,2nd, Scambia G, Fanfani F, Paglia A, Escobar PF. First 100 early
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9. Jennings AJ, Spencer RJ, Hanks L, Barroilhet L, Kushner D, Rose S, et al. The feasibility and
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Gynecol. 2016 Mar-Apr;23:358-363.
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10. Tergas AI, Fader AN. Laparoendoscopic single-site surgery (LESS) radical hysterectomy for
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the treatment of early stage cervical cancer. Gynecol Oncol. 2013 Apr;129(1):241-3.
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11. Boruta DM, Fagotti A, Bradford LS, Escobar PF, Scambia G, Kushnir CL, et al.
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Laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy: Initial multi-
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2014 May-Jun;21(3):394-8.
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12. Gunderson CC, Knight J, Ybanez-Morano J, Ritter C, Escobar PF, Ibeanu O. The risk of
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13. Agaba EA, Rainville H, Ikedilo O, Vemulapali P. Incidence of port-site incisional hernia
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after single-incision laparoscopic surgery. JSLS. 2014 Apr-Jun;18(2):204-10.
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14. Antoniou SA, Morales-Conde S, Antoniou GA, Granderath FA, Berrevoet F, Muysoms FE,
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19. Coda A, Bossotti M, Ferri F, Mattio R, Ramellini G, Poma A, et al. Incisional hernia and
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20. Crist DW, Gadacz TR. Complications of laparoscopic surgery. Surg.Clin.North Am. 1993
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21. Kadar N, Reich H, Liu CY, Manko GF, Gimpelson R. Incisional hernias after major
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22. Montz FJ, Holschneider CH, Munro M. Incisional Hernia Following Laparoscopy: A Survey
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Table 1: Demographic data for patients undergoing Single Port Laparoscopy
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24(2.7) 459(50.8) 404(44.7) 16(1.8) 144(15.9) 11(1.2) 88(9.7) 112(12.3) 12(10.9) 98(89.1) 49(5.4) 81(8.9) 5(0.55)
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793(87.9) 4(0.44) 86(9.5) 9(1.00) 10(1.1) 29.6±7.5
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Total (N=908) 55.7±13.0
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Factor Age (years) Race Caucasian Hispanic African American Asian Pacific Islander Other BMI (kg/m2) ASA I II III IV Smoking at the Time of Surgery Neoadjuvant chemotherapy Adjuvant chemotherapy Radiation Before surgery After surgery Pelvic RT Vaginal Brachytherapy Extended field RT Medical comorbidities Diabetes Mellitus HTN Obesity Pulmonary disease Immunosuppression Coronary artery disease Peripheral vascular disease Hormone replacement In the past Until surgery Never Indication for Surgery Adnexal mass Endometrial hyperplasia or cancer Cervical dysplasia or cancer Molar pregnancy or GTN Ovarian, fallopian tube or peritoneal carcinoma Risk reduction surgery Personal history of breast cancer
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374 375
139(15.3) 390(43.0) 338(37.2) 107(11.8) 4(0.44) 85(9.4) 29(3.2) 360(39.7) 138(15.2) 408(45.0) 335(36.9) 339(37.3) 40(4.4) 2(0.22) 49(5.4) 128(14.1) 126(13.9)
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Prior abdominal surgeries
1.08±1.3
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Statistics presented as Mean ± SD or N (column %). ASA, American society of Anesthesiologists; BMI, body mass index; RT, radiation therapy; HTN, hypertension; GTN, gestational trophoblastic neoplasia
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376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402
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Table 2: Intra-operative data for patients undergoing Single Port Laparoscopy
SC
569 (62.7) 782 (86.1) 781 (86.0) 746 (82.2) 729 (80.3) 126 (13.9) 67 (7.4) 79 (8.7) 44 (4.8) 16 (1.8) 5 (0.6) 5 (0.6) 3 (0.3) 36 (3.9) 121.8±69.1 65.0±114.1 13(1.4) 3 (0.3) 2 (0.2) 5 (0.5) 1 (0.1) 35 (3.9) 6 (0.7) 29 (3.2) 4(0.44) 45 (5.0)
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Total (N=908)
405 406 407 408
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Factor Procedure Hysterectomy Right salpingectomy Left salpingectomy Right oophorectomy Left oophorectomy Pelvic lymphadenectomy Para-aortic lymphadenectomy Omenectomy Peritoneal biopsies Appendectomy Small bowel surgery Large bowel surgery Trachelectomy Sentinel lymph node mapping Operative Time (minutes) EBL (mL) Intraoperative injury Bowel Bladder Ureters Major vascular injury Conversion Multiport laparoscopy Laparotomy Intraoperative transfusion Hand assist
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Statistics presented as Mean ± SD or N (column %). EBL, estimated blood loss
409 410 411 412 413
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Total (N=908) 1 (0.1) 4 (0.4) 7 (0.8) 37 (4.0) 16 (1.7) 26 (2.8) 2 (0.2) 1 (0.1)
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Factor Re-operation within in <48 hours Unplanned ICU admission in 30 days Postoperative transfusion in 30 days Postoperative fever within 30 days Urinary retention within 30 days UTI within 30 days of surgery DVT within 30 days of surgery PE within 30 days of surgery Delayed injury diagnosed within 30 days of surgery Bowel Bladder Ureter Incisional Cellulitis within 30 days of surgery Deep wound infection within 30 days of surgery Vaginal cuff dehiscence within 30 days of surgery Readmission within 30 days Incisional hernia Time to hernia development (days)
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Table 3: Short term postoperative outcomes and hernia outcome in patients undergoing Single Port Laparoscopy
SC
414 415 416
423
10 (1.1)
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1 (0.2)
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31 (3.4) 50 (5.5) 570.2±553.3
Post-operative outcomes presented as N (%). Time to hernia development is presented as median time to hernia development in days (+/- range). ICU, intensive care unit; UTI, urinary tract infection; DVT, deep venous thrombosis; PE, pulmonary embolism
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417 418 419 420 421 422
1 (0.1) 1 (0.1) 1 (0.1) 32 (3.5)
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Table 4. Hernia-free survival for patients undergoing Single Port Laparoscopy Variable 1 Year 2 Years 3 Years Hazard Ratio P(95% CI) value Overall 95.3 (93.6, 91.3 (88.8, 90.5 (87.8, 97.0) 93.8) 93.2) ASA I/II 95.3 (93.0, 93.7 (90.7, 93.7 (90.7, 1.00 0.041 97.8) 96.8) 96.8) ASA III/IV 95.3 (92.9, 88.8 (84.9, 87.2 (82.8, 1.81 (1.02, 3.19) . 97.7) 93.0) 91.9) Current Smoking 96.0 (92.2, 88.9 (81.6, 88.9 (81.6, 1.02 (0.48, 2.17) 0.95 99.9) 96.8) 96.8) 0.77 Chemotherapy 94.8 (89.9, 90.5 (83.3, 90.5 (83.3, 1.14 (0.47, 2.77) 99.9) 98.3) 98.3) 0.21 Pelvic radiation 93.6 (88.8, 88.0 (80.5, 84.4 (74.7, 1.58 (0.78, 3.23) 98.7) 96.3) 95.4) Chemotherapy + Radiation 95.7 (89.9, 91.8 (83.0, 91.8 (83.0, 1.00 (0.36, 2.75) 0.99 100) 100) 100) Diabetes Mellitus 92.2 (87.1, 79.3 (70.2, 77.0 (67.3, 3.60 (2.02, 6.41) <0.001 97.5) 89.5) 88.1) HTN 94.2 (91.4, 88.8 (84.7, 87.1 (82.5, 1.81 (1.02, 3.20) 0.04 97.0) 93.1) 92.0) Obesity 91.8 (88.4, 87.1 (82.5, 84.9 (79.6, 3.23 (1.74, 5.99) <0.001 95.3) 91.8) 90.5) 0.71 Pulmonary Disease 98.7 (96.3, 95.6 (90.8, 90.1 (81.6, 0.74 (0.30, 1.86) 100) 100) 99.4) Coronary Artery Disease 93.2 (87.0, 91.1 (83.9, 88.1 (79.4, 1.18 (0.50, 2.75) 0.12 99.9) 98.9) 97.9) Race (Not Caucasian) 98.7 (96.2, 96.4 (91.4, 96.4 (91.4, 1.00 0.13 100) 100) 100) Race (Caucasian) 94.9 (93.0, 90.6 (87.9, 89.8 (86.8, 3.01 (0.73, . 96.8) 93.4) 92.8) 12.41) Adenexal/Ovarian Mass 93.9 (90.5, 92.3 (88.2, 92.3 (88.2, 0.79 (0.42, 1.52) 0.48 97.5) 96.5) 96.5) Endometrial Cancer 96.0 (93.7, 89.9 (85.9, 88.1 (83.6, 1.50 (0.84, 2.69) 0.65 98.4) 94.0) 92.9) Ovarian/Fallopian Tube 94.9 (88.2, 87.0 (75.5, 87.0 (75.5, 1.27 (0.46, 3.48) 0.15 Carcinoma 100) 100) 100) Risk Reduction Surgery 100 (100, 97.4 (92.6, 97.4 (92.6, 0.23 (0.03, 1.69) 0.96 100) 100) 100)
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Hysterectomy
3 Years
94.1 (88.7, 99.9) 96.7 (90.5, 100) 95.7 (93.8, 97.7) 93.4 (90.0, 96.9) 92.8 (87.5, 98.6) 94.3 (89.1, 99.9)
90.8 (84.1, 98.1) 87.9 (75.7, 100) 90.3 (87.1, 93.7) 90.5 (86.2, 95.0) 89.6 (82.9, 96.8) 85.2 (75.9, 95.8)
90.8 (84.1, 98.1) 87.9 (75.7, 100) 89.2 (85.6, 92.9) 89.6 (84.9, 94.4) 86.8 (78.6, 95.9) 85.2 (75.9, 95.8)
Hazard Ratio (95% CI) 1.02 (0.43, 2.44)
Pvalue 0.64
1.32 (0.42, 4.17)
0.27
1.45 (0.75, 2.78)
0.65
1.63 (0.82, 3.25)
.
1.98 (0.86, 4.57)
.
2.23 (0.88, 5.62)
425
Hernia free survival presented as N, indicating the frequency of patients not diagnosed with a
427
hernia at each time point (interquartile range). Hazard ratios are presented along with 95%
428
confidence interval and P values with <0.05 considered significant.
429
ASA, American Society of Anesthesiologists; HTN, hypertension.
433 434 435 436
EP
432
AC C
431
TE D
426
430
.
M AN U
Prior Abdominal Surgeries
2 Years
RI PT
Personal History of Breast Cancer Hand Assist
1 Year
SC
Variable
437 438 439
23
ACCEPTED MANUSCRIPT
440 441
AC C
EP
TE D
M AN U
SC
RI PT
442
24
ACCEPTED MANUSCRIPT
Figure Legend
444
Figure 1: Multi-instrument single incision platform demonstrating a typical instrument set up.
445
Table 1: Demographic data for patients undergoing Single Port Laparoscopy
446
Table 2: Intraoperative data for patients undergoing Single Port Laparoscopy
447
Table 3: Short term postoperative outcomes and hernia outcome in patients undergoing Single
448
Port Laparoscopy
449
Table 4. Hernia-free survival for patients undergoing Single Port Laparoscopy
SC
RI PT
443
450
AC C
EP
TE D
M AN U
451
25
AC C
EP
TE D
M AN U
SC
RI PT
ACCEPTED MANUSCRIPT