Use of “Person-Centered” Analyses When Outcomes of Interest Are Not Homogeneous in Hysterectomy Patients

Use of “Person-Centered” Analyses When Outcomes of Interest Are Not Homogeneous in Hysterectomy Patients

Abstracts / Journal of Minimally Invasive Gynecology 19 (2012) S36–S70 S65 Results and follow-up of treatment Patients 3 months 6 months 9 months...

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Abstracts / Journal of Minimally Invasive Gynecology 19 (2012) S36–S70

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Results and follow-up of treatment Patients

3 months

6 months

9 months

12 months

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complex hyperplasia proliferative endometrium simple hyperplasia simple hyperplasia with atypia proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium simple hyperplasia proliferative endometrium complex hyperplasia

simple hyperplasia proliferative endometrium simple hyperplasia simple hyperplasia proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium simple hyperplasia

proliferative endometrium proliferative endometrium proliferative endometrium simple hyperplasia proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium proliferative endometrium simple hyperplasia

proliferative proliferative proliferative proliferative proliferative proliferative proliferative proliferative proliferative proliferative proliferative proliferative

endometrium endometrium endometrium endometrium endometrium endometrium endometrium endometrium endometrium endometrium endometrium endometrium

operative hysteroscopy more diu-lng.

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Open Communications 11dHysteroscopy (11:48 AM d 11:53 AM)

Comparative Effectiveness of Hysteroscopic Morcellation Versus Loop Electrode Resection for Lesions in the Endometrial Cavity Smith ER, Hoffman MK, Makai GE. Obstetrics and Gynecology, Christiana Care Health System, Newark, Delaware Study Objective: To determine the comparative effectiveness of hysteroscopic morcellation versus loop resection for the removal of intrauterine lesions. Design: Retrospective cohort study, Canadian Task Force Level II-2. Setting: Hospital-based ambulatory surgery center. Patients: All women undergoing outpatient surgery for lesions of the endometrial cavity between January 2010 and December 2011 were evaluated for inclusion. Of 396 women eligible for our study, 138 were excluded for having multiple concurrent procedures. A total of 258 women were analyzed on an intention-to-treat basis between the hysteroscopic morcellation (n = 114) and loop electrode (n = 144) groups. Intervention: Cervical dilation, hysteroscopy with diagnosis of an intrauterine lesion, and subsequent removal of the lesion using a hysteroscopic morcellator (MyosureÓ) or conventional wire loop electrode, with or without endometrial currettage. Measurements and Main Results: The surgical procedure and hospital records within 14 days were reviewed. The primary outcome measure was time for the operative procedure. Secondary outcome measures included cost and complications. The hysteroscopic morcellator and loop electrode groups were not significantly different when comparing age (mean, in years, 49.5 versus 50.4, p = .50), insurance (p = 0.89), and indication for surgery. Compared with loop electrode group, operative time for hysteroscopic morcellation procedures was not shorter (mean time in minutes = 37, versus 33 for the loop, p = 0.15), nor was overall time in the OR (mean time, in minutes = 58, versus 54 for the loop, p = 0.22). Total charges were significantly higher for the hysteroscopic morcellation procedures (mean $6,829 versus $3,930 for the loop, p\.01), but reimbursement was also higher (mean $5,274 versus $3,130 for the loop, p\.01). There were no major complications in either group. Conclusion: In this broad population, utilization of the hysteroscopic morcellator for removal of intrauterine lesions was not more effective than the loop electrode, and was associated with signficantly higher costs. Optimal use of this technology needs further definition. 190

Open Communications 11dHysteroscopy (11:54 AM d 12:00 AM)

Extirpated Uterine Endometrial Ablation with CARDEA Bipolar RF Uterine Ablation System Xu H, Cao L, Wang Y, Yan X, Liang Z. Obstetrics and Gynecology, Southwest Hospital, Third Military Medical University, Chongqing, China

Study Objective: To determine the in-vivo necrosis formation in extirpated uteri model utilizing CARDEA Uterine Ablation System, a novel bipolar RF endometrial ablation device. Design: A prospective single center observational study. Setting: Laboratory in a clinical hospital. Patients: Five uteri obtained immediately after hysterectomy, samples are from pre-menopausal women between 30 and 50 years old. Intervention: The uteri were subjected to CARDEA bipolar RF ablation in a 37 C water bath. Measurements and Main Results: Specimens were sectioned and stained with Tetrazolium Blue Chloride, and samples were also stained with H&E to determine the region of necrosis. The depth of necrosis observed by tetrazolium blue staining ranges from 4 to 10 mm, with a mean of 6.77 mm and stdev of 1.50 mm; by H&E ranges from 4 to 10 mm, with a mean of 6.44 mm, stdev: 1.53 mm. Complete and uniform ablations were observed throughout the whole cavity of uteri. Conclusion: The CARDEA bipolar RF endometrial ablation achieves excellent in-vivo necrosis of uterine tissue and complete destruction of endometrial layer. 191

Open Communications 12dLaparoscopy (11:00 AM d 11:05 AM)

Use of ‘‘Person-Centered’’ Analyses When Outcomes of Interest Are Not Homogeneous in Hysterectomy Patients Sangha R,1 Dahlman M,1 Nawfal K,2 Eisenstein D,1 Orady M,3 Havstad S,1 Wegienka G,1 Lawrence F.1 1Henry Ford Hospital, Detroit, Michigan; 2Clemenceau Medical Center, Beirut, Lebanon; 3Cleveland Clinic, Cleveland, Ohio Study Objective: To demonstrate several statistical models (latent class analysis - LCA, latent class growth analysis LCGA, and growth mixture modeling - GMM) that use a ‘‘person-centered’’ focus. Design: Prospective cohort study. Setting: Henry Ford Hospital (Detroit, MI). Patients: Hysterectomy patients (n = 245). Intervention: Hysterectomy. Measurements and Main Results: Participants completed a baseline interview about their demographic information, pain and daily functioning. Phone interviews to obtain health status updates using a validated quality of life questionnaire were made to women after their surgery. The intervals for these calls were 4, 7 and 14 days and 4, 6, 8 and 12 weeks after surgery. LCA was used to characterize the women in terms of their response patterns on quality of life issues. There were 2 ‘‘classes’’ of women and they had differing baseline characteristics with respect to mobility, self-care and well-being. LCGM analyses revealed heterogeneity in the response patterns with one group having a higher reported well-being. Class 1 tended to have more pain and less energy at baseline and 3 months after surgery. Women in class 1 reported lower well-being throughout the follow up period. Both groups demonstrated

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Abstracts / Journal of Minimally Invasive Gynecology 19 (2012) S36–S70

improved well-being after surgery. GMM analysis yielded three distinct groups for the outcome of energy. One group had low assessment of their energy and, while it increased slightly, it remained low relative to the other classes over follow up. Another group had a high perception of their energy just prior to surgery and it increased following surgery. The other group had a low pre-surgery energy level but increased post-surgery. Differences existed between the groups in reported pain with one class indicating higher pain (the group reporting the lowest energy over time) and all three differed at study’s end. Conclusion: ‘‘Person-centered’’ analyses are appropriate for study of populations that aren’t homogeneous with respect to the outcome of interest.

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Open Communications 12dLaparoscopy (11:06 AM d 11:11 AM)

Cost-Effective Analysis of Universal Cystoscopy in Identification of Urinary Tract Injury by Hysterectomy Route Chudnoff S, Levie M, Gupta D, Hadpawat A. Obstetrics & Gynecology and Women’s Health, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York Study Objective: To evaluate the cost-effectiveness of performing cystoscopy for all hysterectomy approaches including abdominal, vaginal, laparoscopic, and robotic assisted in regards to detection of urinary tract injury and potential outcome. Design: Decision analysis models were constructed for use of cystoscopy at the time of abdominal, vaginal, laparoscopic and robotic assisted hysterectomies. Models were constructed from both a societal perspective and a hospital-based prospective. Each model looked at outcomes regarding identified versus unidentified bladder and ureteral injuries as well as associated costs. Incidences and outcomes were determined by a review of published literature of all hysterectomy routes. Cost estimates were based on publicly available reimbursement data. Sensitivity analyses were performed for several of the variables within the model. Setting: Women undergoing hysterectomy for benign indications for all surgical approaches. Intervention: Diagnostic cystoscopy performed at the time of hysterectomy. Measurements and Main Results: The performance of cystoscopy during hysterectomy had a relatively small cost per procedure. When utilizing currently reported rates of ureteral injury during hysterectomy, the cost savings associated with early identification and repair of ureteral and bladder injuries was significantly greater than the incremental costs of performing cystoscopy to identify each injury. This finding was present regardless of perspective or route of hysterectomy. This finding was especially significant for laparoscopic hysterectomy given the higher incidence of reported ureteral injury in this route. Conclusion: It is cost-effective from both a societal and hospital perspective to perform universal cystoscopy to identify urinary tract injuries at the time of hysterectomy indepedent of surgical route.

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Open Communications 12dLaparoscopy (11:12 AM d 11:17 AM)

Morcellation during Laparoscopic Hysterectomy/Myomectomy and Associated Complications Pereira N, Badia CR. Della. Department of Obstetrics and Gynecology, Hahnemann University Hospital, Philadelphia, Pennyslvania Study Objective: Investigate all reported gynecological complications associated with morcellating surgical specimens during laparoscopic hysterectomy (total and supracervical) and myomectomy. Design: MEDLINE search using PubMed with search terms that included ‘‘uterine morcellation,’’ ‘‘complications,’’ ‘‘laparoscopy,’’ and ‘‘hysterectomy.’’ Out of a total of 115 publications, only cases of patients undergoing laparoscopic hysterectomy (total and supracervical) or myomectomy with uterine morcellation followed by a second surgical procedure due to onset of

new symptoms or cases wherein final pathological evaluation of surgical specimens were inconsistent with the initial indication for laparoscopic hysterectomy (total and supracervical) or myomectomy were included in the analysis. Robot-assisted cases were not included in this analysis. Setting: All cases were reported from large community and academic hospitals in the U.S.A. and the rest of the world. Patients: 39 patients were identified through 21 publications that included case reports and care series. All patients presented with clinical complications associated with the original laparoscopic surgery and morcellation procedure. Measurements and Main Results: Patients differed in their ages (range 24-48), parity, ethnicity and initial diagnostic work-up. All patients underwent pre-operative imaging prior to surgery. 21 (54%) patients underwent either a laparoscopic total or supacervical hysterectomy for conditions ranging from chronic pelvic pain, menorrhagia and leiomyoma. The remaining 18 (46%) patients underwent laparoscopic myomectomy for symptomatic leiomyoma. All surgical cases included the use of a uterine morcellator. On re-presentation, 18 (46%) patients were found to have parasitic leiomyoma, 10 (26%) patients with iatrogenic endometriosis and adenomyosis, 6 (15%) patients with disseminated peritoneal leiomyomatosis and the rest 5 (13%) patients with final histopathologic evaluation that revealed occult carcinoma. Conclusion: Although morcellation is not without complications, the overall complication rate in the context of all laparoscopic surgeries done is minimal.

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Open Communications 12dLaparoscopy (11:18 AM d 11:23 AM)

The Evaluation on the Results of the Laparoscopic Transperitoneal Ureteroureterostomy for the Injured Ureter during Gynecologic Laparoscopic Operation Eun D, Shin K, Choi Y, Oh Y, Kim H, Park J. Obstetrics and Gynecology, Eun’s Hospital, Gwangju, Jeonlanmado, Republic of Korea Study Objective: To evaluate the efficacy and feasibility of laparoscopic transperitoneal ureteroureterostomy with the same route as the previous laparoscopic hysterectomy. Design: Prospective analysis from Jan.2000 to Dec.2011. Setting: Eun’s laparoscopic gynecologic hospital in South Korea. Patients: 83 patients who were undergone the laparoscopic ureteroureterostomy for the injured ureter after laparoscopic myomectomy and hysterectomy. Intervention: Through the right 5mm port, the whole length of double J stent containing the guide wire were inserted into the abdominal cavity laparoscopically. The injured ureter can normally be identified reliably as it appears almost around the uterine artery. The distal end of a 6FR ureteral stent was inserted into the bladder via distal injured ureter

Characteristics The comparision of laparoscopic gynecologic operation according to detection time of injured urter Detection type Intraoperative detection with U-Ustomy - LH Delayed detection with U-Ustomy - LH - LM - L.ovarian cystectomy Characteristics of Transperitoneal Laparoscopic Ureteroureterostomy Characteristics Operation time Age of patients

Number(%) 22 (26.5) 22 61 52 7 2

(100) (73.5) (85.2) (11.5) (3.3)

Mean numberSD (range) 68.42 (SD27.88) 51.23 (SD8.41)