Robotic Single-Site Myomectomy: Clinical Analysis of 61 Consecutive Cases

Accepted Manuscript Robotic Single-Site Myomectomy: Clinical Analysis of 61Consecutive Cases Eun Ji Choi, MD., A Mi Rho, MD., Sa Ra Lee, MD., PhD., Kyungah Jeong, MD., PhD., Hye-Sung Moon, MD, PhD PII:

S1553-4650(17)30129-2

DOI:

10.1016/j.jmig.2017.02.003

Reference:

JMIG 3061

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 2 November 2016 Revised Date:

3 February 2017

Accepted Date: 4 February 2017

Please cite this article as: Choi EJ, Rho AM, Lee SR, Jeong K, Moon HS, Robotic Single-Site Myomectomy: Clinical Analysis of 61Consecutive Cases, The Journal of Minimally Invasive Gynecology (2017), doi: 10.1016/j.jmig.2017.02.003. 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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Robotic Single-Site Myomectomy: Clinical Analysis of 61Consecutive Cases

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Eun Ji Choi MD., A Mi Rho MD., Sa Ra Lee, MD., PhD.,Kyungah Jeong, MD., PhD., Hye-Sung Moon, MD,

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PhD.

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Department of Obstetrics and Gynecology, Robot Surgery Center, School of Medicine,

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Ewha Womans University, Korea

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6 Corresponding author contact information: Hye-Sung Moon, MD., PhD.

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1071, Anyangcheon-ro, Yangcheon-Gu, Seoul, 07985, Republic of Korea

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Tel.: +82-2-2650-5033, Fax: +82-2-2647-9860, E-mail: [email protected]

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Keywords: Robotic Single-Site Myomectomy, Myoma

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There was no financial support provided for this study.

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Conflicts of Interest: The authors declare no conflicts of interest.

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Abstract

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Study objective: To report 61 consecutive cases of successful robotic single-site myomectomy(RSSM) and to

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evaluate the feasibility and safety of RSSM.

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Design: Retrospective analysis of 61 cases of RSSM

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Design Classification: Canadian Task Force classification III

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Setting: Department of Obstetrics and Gynecology, School of Medicine, Robot Surgery Center, Ewha Womans

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University

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Patients: 61 patients who had RSSM

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Interventions: Patients underwent RSSM by 3 gynecologic surgeons at Ewha Womans University Medical

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Center from December 2014 to May 2016. We analyzed the patients’ baseline characteristics and surgical

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variables and the trends of operation-related variables according to the surgeon’s experience.

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Measurements and main Results: There was no case of conversion to laparotomy or robotic multi-site

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myomectomy. RSSM was successful for multiple uterine myomas up to 12in number and large myomas up to

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12.8 cm in longest diameter. In terms of location of myoma, RSSM was successful for all types of myoma

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including subserosal, intramural, or intraligamentary type. The mean docking time was 5.45 ± 2.84 (2.00~12.00)

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min, mean total operation time was 135.98 ± 59.62 (60~295), mean estimated blood loss was 182.62 ± 153.02

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(10~600) mL, and mean skin incision size was 2.70 ± 0.19 (2.4~3.10)cm. The mean time to postoperative gas

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passage was 28.71 ± 12.99 (3.33~76.50) hours, and mean duration of hospitalization was 4.21 ± 0.84 (3~6)days.

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There was no case requiring additional analgesics other than applied IV PCA. The mean change in hemoglobin

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level was 2.43 ± 0.87g/dL, and the rate of postoperative anemia requiring blood transfusion was only 3.3% (2

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cases). No intraoperative or perioperative complication were noted.

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Conclusion: RSSM is a feasible and safe procedure even when the myoma is large, multiple, and intramural

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type. Therefore, this option could be extended to appropriately selected patients.

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Introduction

2 Laparoendoscopic surgery has been used by gynecologic surgeons for decades. Compared with laparotomy,

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laparoendoscopic surgery has the advantages of shorter hospitalization, faster recovery, less morbidity, and

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better cosmetic outcome. (1-3).

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Laparoendoscopic surgery has been used by gynecologic surgeons for decades. Compared with laparotomy,

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laparoendoscopic surgery has the advantages of shorter hospitalization, faster recovery, less morbidity, and

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better cosmetic outcome.

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However, laparoendoscopic myomectomy has some limitations due to the rigidity of the instrument. It is

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difficult to identify an appropriate plane, especially in deep-seated myomas, in order to perform a strong and

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layered closure for defect sites and to perform myomectomy by the single-port approach.(1).

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The da Vinci Robotic Surgical System was developed for laparoendoscopic surgery in 2000, and was approved

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by the U.S. Food and Drug Administration in 2005 for use in gynecologic surgery.(1). Adoption of the Robotic

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Surgical System for gynecologic surgery made it possible to overcome the weaknesses of laparoendoscopic

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myomectomy.(4-6).

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Due to the ability of single-port laparoscopy to reduce pain and improve satisfaction of patients (7), robotic

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single-site surgery was developed and introduced to the field of robotic surgery.

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Until now, the use of robotic single-site surgery has been limited to the department of general surgery and

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gynecologic surgery. Especially, in gynecologic robotic surgery, hysterectomy is performed by Single-Site®,

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but myomectomy is usually performed at multiple sites because of limitations.(8,9).

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In this study, we report 61 cases of successful robotic single-site myomectomy(RSSM) and evaluate applicable

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ranges of RSSM using the da Vinci Si Surgical System in terms of feasibility, safety, and potential advantages.

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Materials and Methods

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We retrospectively collected 61 consecutive cases of RSSM using the da Vinci Si Surgical System with SingleSite platform at Ewha Womans University Medical Center from December 2014 to May 2016.

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We consecutively have performed RSSM to the patients if they had a few numbers of myoma, the longest

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diameter of myoma to 12cm, myoma without severe adenomyosis and without deep seated myoma to the

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endometrium.

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The procedure of RSSM was as follows. After anesthetizing and draping the patient, a Valtchev® VUM-5

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Uterine (Conkin surgical instruments LTD, Toronto, Canada) was placed, and a Foley catheter was inserted into the bladder. The da Vinci Single-Site® platform was applied with a specialized silicone port and a curved

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cannula with a flexible instrument for RSS surgery. A vertical 2.5-2.7cm transumbilical skin incision was

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created, and the fascia layer was opened in the same direction using the open Hasson technique. The total length

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of the umbilical incision was 2.5 cm at the level of the skin and approximately 3 cm at the level of the

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underlying fascia and peritoneum. We inserted a size S Alexis® wound protector (Applied Medical, Rancho

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Santa Margarita, CA, USA) into the fascial opening to facilitate removal of the specimen during the final

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surgical procedure. The silicon port for the da Vinci Single-Site® was inserted through the Alexis-applied

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opening using long Kelly forceps and an Army-Navy retractor. A pneumoperitoneum was created via carbon

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dioxide gas inflation to 12 mm Hg. The30-degree 8.5-mm da Vinci stereolaparoscope connected to the robotic

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system camera was then inserted to confirm atraumatic placement of its primary port while the patient was in a

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20-degree Trendelenburg angle position. Then the camera was removed, and the robotic system was positioned

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centrally between the patient's legs and docked at the camera port. After these processes, the two 5-mm curved

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instrument cannulas were inserted into the docked robotic arms, and the dedicated semirigid instruments were

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loaded under careful stereolaparoscopic guidance. Flexible robotic instruments (a monopolar hook and

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fenestrated bipolar forceps) were mounted through the curved cannulas, and the robotic system provided a

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switching motion between right-hand and left-hand orientations.

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We assessed the whole uterus and made incisions on the most protruding portion of each myoma in order to expose the myoma capsule using the monopolar hook(Fig. 1). Myomas were extracted from the uterus by repeat

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electrocauterization and cut using the monopolar hook, which was kept in traction using the claw forceps

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inserted through the assistant’s port. The uterine myometrium and serosa were sutured layer by layer for more

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than 3 layers using continuous running 0-V Loc™ sutures (Covidien, Dublin, Ireland) with a wristed needle

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driver (Fig. 2). The extracted myomas were placed into an Endopouch® specimen retrieval bag (Ethicon,

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Johnson & Johnson, New Brunswick, NJ) using both bipolar forceps and a wristed needle driver (Fig. 3). The

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specimen in the Endopouch® was easily removed from the peritoneal cavity through the Alexis® after mincing

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with a knife. Then, the single-site port was reinserted, and 3 reusable straight trocars were placed to assess the

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pelvic cavity and irrigate the blood. The fascia was closed with absorbable continuous locking sutures, and

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subcutaneous closure was approximated with 3-0 Vicryl sutures.

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All RSSM procedures were performed by three gynecologic surgeons who are experts in robotic surgery and

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had experienced more than 200 cases robotic gynecologic surgery and completed robotic single-site surgery

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training and earned an RSSS Certificate. We collected the data on patient baseline characteristics that might

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influence surgical outcomes such as age, parity, body mass index, and history of abdominal or pelvic surgery.

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Also, we analyzed several variables regarding uterine myoma such as the number, size, and location estimated

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preoperatively using pelvic ultrasonography or pelvis magnetic resonance imaging (MRI). We also extracted the

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number of extracted myoma counted postoperatively. Surgery-related data including robot docking time, total

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operation time(TOT), estimated blood loss(EBL), sizes of the umbilical incision and postoperative scar, time to

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postoperative gas passage, and duration of hospitalization.

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We analyzed the date of 61 case by descriptive statistics, one-way ANOVA analysis, Kruskal-Wallis analysis,

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and linear regression analysis using SPSS (version 18). This study was approved by the Institutional Review

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Board of our institute (No. 05-038-003).

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Results

2 All RSSMs were completed successfully without conversion to laparotomy or robotic multi-site myomectomy.

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Patients who underwent RSSM were mostly reproductive age; in terms of parity, 34 patients were nullipara, 14

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had one baby, and 13 had two or more babies (Table 1). The mean body mass index(BMI) of the patients was

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(17.63 to 38.00) kg/m2,and 16 patients (26.2%) had a history of abdominal or pelvic surgery. Thirty-four

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patients had one myoma, and 24 patients had fewer than 5 myomas. In most cases (51 of 61 cases), the longest

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diameter of the largest myoma was over 5 cm.

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According to our experience, RSSM was feasible in multiple uterine myomas, up to 12 myomas in one patient, and in large myoma up to 12.8 cm in largest diameter. In terms of location, most myomas were in the anterior

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wall (39.3%) or posterior wall (36.1%) of the uterus. RSSM was successful for all types of myomas, including

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subserosal type (24.6%), intraligamentary type (3.3%), and intramural type(65.6%). Neither location nor type of

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myoma was a limitation for RSSM.

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The mean docking time was 5.45 ± 2.84 (2.00-12.00) minutes, mean total operation time was 135.98 ± 59.62

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(60.00-295.00) minutes, mean estimated blood loss was 182.62 ± 153.02 (10.00-600.00) mL, and mean size of

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intra umbilical skin incision was 2.70 ± 0.19 (2.40-3.10) cm (Table 2).

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There was no need for additional analgesics. All cases were tolerable of routine patient-controlled analgesics

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(PCA) administered intravenously or non steroidal anti-inflammatory drugs (NSAIDs) administered

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intravenously 3 times a day until the second postoperative day. Then, the IV-PCA was removed or the injected

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analgesics were changed to oral analgesics. There were no patients who complained of postoperative pain.

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The mean time to postoperative gas passage was 28.71 ± 12.99 (3.33~76.50) hours, and the mean duration of

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hospitalization was 4.21 ± 0.84 (3.00~6.00) days. We usually keep the urethral Foley catheter for 24 hours after

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operation. On the next day of the operation, we removed urethral Foley catheter after checking urine output and

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ambulation status. The mean time to Foley catheter maintenance time was 24.41 ± 4.02 (17.00~38.00) hours.

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There was no case of urinary retention.

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There were no postoperative complications. The average change in hemoglobin(Hb) level was 2.43 ± 0.87g/dL. Severe anemia requiring blood transfusion was noted in two patients. One case was a woman with severe pelvic

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adhesion with previous cesarean section history who had a total of four leiomyomas of intramural type with a

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maximum diameter of 9.5cm. The preoperative Hb level in this patient was 10.4g/dL, and the postoperative Hb

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level was 8.0g/dL, with an estimated blood loss of 600cc. The other case was a woman with multiple myomas

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combined with preoperative ovary bleeding and hematoma. Her preoperative Hb level was 9.8g/dL, and

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postoperative Hb level was 7.3g/dL, so 2 pints of RBC transfusion were needed.

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We compared total operation time and EBL according to type and size of myomas (Tables 3, 4). The mean total

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operation time was 97.50 ± 2.12 min, 140.25 ± 64.97 min, and 178.75 ± 52.66 min for intraligamentary type,

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intramural type, and mixed type, respectively (p=.178) (Table 3). Mean EBL was 195.25 ± 153.63 ml, 150.67 ±

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152.20 ml, and 162.50 ± 94.65 ml for intramural type, mixed type, and subserosal type, respectively (p=.755).

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In terms of the difference in operative outcomes according to the size of uterine myomas, we divided the 61

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cases into three groups depending on the largest diameter of myoma (<6cm, 6-10cm, >10cm); the mean

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diameter of myoma among the three groups was 4.99 ± 0.79 cm, 7.33 ± 0.90 cm, and 11.66 ±0.99 cm,

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respectively (Table 4). There was no statistical difference in TOT, postoperative gas passage time, or average

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number of myomas. EBL was lowest in the myoma group under 6cm in largest diameter (132.80 ± 122.32 mL)

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compared with the other two groups (210.97 ± 157.72 mL and 256.00 ± 215.48 mL), which was a statistically

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significant trend (p=.078). As the size of myoma increased, operation time and value of estimated blood loss

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also increased. The largest myoma group (>10cm) had the longest time to postoperative gas passage and

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hospital stay compared with the other two groups (p>.05).

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To compare the surgical outcome according to surgeon experience, we analyzed the surgical outcomes

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according to the time period when RSSM was performed (Table 5, Fig. 4). The time period of RSSM was

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divided into three 6-month periods from November 2014 to May 2016. The number of RSSM cases was 14, 30,

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and 17 for the respective time periods, and the size and number of myomas were not different among periods

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(p=.320, p=.550). Docking time became significantly shorter in the third 6-month period compared with the

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previous 12-months (p=.006). The mean total operation time decreased with statistical significance among the 3

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groups (177.14 ± 77.95 min, 135.33 ± 51.24 min, and 103.24 ± 31.82 min, p=.009). Duration of hospitalization

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decreased in the last period compared to the first two periods (3.82 ± 0.64, 4.71 ± 0.61,and 4.20 ± 0.92, p=.008).

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Mean EBL decreased in the last 6-month period compared to the first and second 6-month periods, but the

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difference was not significant (164.71 ± 143.27 mL, 189.29 ± 144.35 mL, and 189.67 ± 165.89 mL, p=.724).

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Postoperatively, there were no complications related to the single-site wound such as infection or dehiscence, and all patients were satisfied with the cosmetics. Preoperative main symptoms were menorrhagia,

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dysmenorrhea, and pressure symptom including urinary frequency. Most symptoms were almost relieved with

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satisfaction after operation. A few patients had still experienced menorrhagia (8.2%). However their symptom

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resolved with medication.

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As far as we know, there was no patient who requiring additional myomectomy or hysterectomy after RSSM in our hospital (during 2 years after our starting RSSM). Among 61 cases, there were four cases of live birth by

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cesarean section (3 cases) and normal spontaneous vaginal delivery (1 case) without complication. Four cases of

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ongoing pregnancy are confirmed. Fortunately, no event of uterine rupture has been reported until now.

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Discussion

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Minimally invasive surgery is currently a safe option due to medical and technological developments. The introduction of a robotic surgical system has helped surgeons overcome the technical challenges of

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laparoendoscopy by improving surgeon dexterity, surgical precision, and visualization (10, 11).

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Laparoendoscopic single-port surgery presents an opportunity to achieve scarless, minimally invasive surgery.

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However, there are surgical difficulties due to limited movement and conflict of instruments (12-14). In

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comparison to laparoendoscopic single-port surgery, the Single-Site® robotic surgical system solves the conflict

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of instruments with better visualization and depth perception. With advanced Endo Wrist technology, robotic

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systems offer surgeons natural dexterity and more free motion of the robotic joint, comparable to movements of

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the human hand and wrist.

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To our knowledge, this report includes the largest number of RSSM cases and is the first report on different

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surgical outcomes according to surgeon experience. We successfully performed RSSM regardless of the type,

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number, and size of myoma up to 12 myomas and up to12.8cm in size. Data from this study indicate that RSSM

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can be successfully performed in any myoma case without limitation in size or number of myomas

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In comparison to the previously reported RSSM (15), our data show a similar total operation time (135.98 ±

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59.62 min) with more total myomas removed. To determine the applicability of RSSM for various types of

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myomas, we analyzed the surgical outcomes according to type of myoma. The postoperative recovery was

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comparable to that previously reported, considering the mean time to postoperative gas passage was around 24

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hours.

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The size of myoma made a difference only in EBL, with no difference in total operation time, time to

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postoperative gas passage, or duration of hospitalization. Therefore, we suggest special caution with EBL when

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RSSM is performed in large myomas.

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Table 5 shows that RSSM significantly decreased the docking and total operation times and EBL. In terms of

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each gynecologic surgeons’ experience, docking time and total operation time were the variable that differed

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(data not shown). Therefore, the experiences of the surgeon conducting RSSM are very important for achieving

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good surgical outcomes in RSSM.

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Our report indicates that RSSM can be successfully used, based on our evaluation of the effect of surgeon

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experience with size and type of myoma. RSSM can be applied to remove subserosal myoma, but not deep-

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seated myoma, and to remove fewer than 10 myomas and myomas smaller than 12 cm, but the uterus must be

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located within the distance of the pubis-to-umbilicus length minus the cannula length. Our study had some

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limitation because we did not analyze postoperative pain with the preset pain control program used in our

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hospital; this topic needs to be addressed

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Our study’s learning curves follow what is called a power law type with operation time, and docking time as

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shown Figure. 4 (16). These times are shortened when more consecutive cases are performed. We assume that

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successful RSSM are largely related to how many cases of multisite robotic myomectomy as well as and single

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port laparoscopic myomectomy cases surgeons have performed. We, three surgeons, are already skilled with

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enucleation of uterine myomas by robotic system (more than 50cases) and single port laparoscopic surgery. The

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learning curve of RSSM is closely related to the time for getting used to manipulating the wristed needle driver

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for suturing as well as flexible single site instrument for holding. Especially, holding point of needle with

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wristed needle driver and the angle of putting needle into the uterine wall oblique direction are the most

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important points of technique. It would be helpful for robotic surgeons to accomplish successful suturing by

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robotic single-site ovarian cystectomy and vault closure of hysterectomy before performing RSSM.

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There are many advantages to robotic single-site surgery. First, it results in improved cosmetic appearances because of the small scar. It is possible to avoid ancillary port complication in comparison to multiport

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laparoendoscopy and to provide shorter hospitalization. It has significantly improved the operative performance

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of myomectomy in providing detailed dissection and a strong suture. The robotic single-site system is also

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ergonomical and more comfortable for surgeons.

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Also, one of the benefits of RSSM over multisite robotic myomectomy is that a shorter time is needed for

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putting myoma specimens out using hand-knife chopping through the relatively large umbilical incision of

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RSSM. This enables a nonvisible scar with good esthetic component, less operative time and less postoperative

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pain.

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Nevertheless, robotic single-site surgery has limits. First, the Robotic Single-Site® System has limited range of

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motion. To improve this limited space, the length of the cannula should be chosen very carefully according to

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the distance between the uterus and the tip of the cannula. Second, the instruments are not jointed, which

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prevents perfect triangulation and makes intracorporeal suturing difficult. Last, bending of the semi-rigid

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instruments prevents the surgeon from achieving appropriate power to the tissue. The Robotic Single-Site

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System has limited instrument working boundary/gas evacuation power. Thus, further instrumental development

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is needed to maximize robotic single-site surgery.

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According to the recent reports, the incisional hernia rate was 6.5% of single site robotic cholecystectomy (17) and 5.8 % for single site robotic colorectal surgery (18). It was reported that the higher rate of incisional hernia

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in single site surgery was due to local ischemia induced by placement of a single large port, which could weaken

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the fascia. Also, potential ischemia combined with increase in the length of incision could contribute to

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incisional hernia. However, we experienced no case of port site umbilical hernia among total 440 cases of the

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robotic single site surgery which we had performed. To prevent port site hernia after RSSM including other

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single site robotic surgery, we make incision as an adequate port size to avoid ischemia on wound, adequate

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burping-up of single site port setting to limit pressure on wound during operation, and make firm suture on the

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peritoneum and fascia. Moreover, we confirm the obliteration of whole umbilical incision at the fascia level

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before proceeding to the subcutaneous and skin suture, although the other report on the port-site hernia

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concluded there is no need for additional procedure to prevent port site hernia after single site surgery (19).

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Therefore, postoperative benefits including esthetic component versus the risk of umbilical hernia justify RSSM.

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Our study clearly supports the safety and feasibility of RSSM in various myomas because we showed satisfactory surgical outcomes. Our study offers the possibility that RSSM is a valuable procedure for young

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women with fewer than 10 myomas and myomas smaller than 12cm. However, a long term follow-up study is

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required to completely appreciate the contribution and impact of RSSM. Also, we need to continue to train more

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doctors to improve the overall skill level with RSSM.

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In Korea, as more and more women are participating in social activities, the trend is shifting toward a delay in

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child bearing. Therefore, the number of patients who need myomectomy with safety and cosmetics increasing,

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and RSSM might be the best option in such applicable cases. After conventional laparoscopic myomectomy,

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uterine rupture during subsequent pregnancy has been reported, even though the previous myoma was

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subserosal type (20). This risk can be mitigated through the use of RSSM.

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Additionally, the laparoendoscopic single-port surgery technique is limited for meticulous suturing, and an

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additional side port is usually needed for myomectomy. For hysterectomy, the decrease in total operative time

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was greater with the robotic single-site approach than with laparoendoscopic single-port surgery(21). There

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appeared to be a linear relationship between vaginal cuff closure time and number of cases performed for

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robotic single-site hysterectomy (22). Because suturing is an important technique for successful myomectomy, RSSM with a wristed semi-rigid

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instrument is a feasible and safe procedure when performed by experienced surgeons, even when myoma is

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large, multiple, and intramural type. Therefore, the indication will be extended by the surgeon’s increased

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experience, and future technology will provide a more comfortable way to accomplish an excellent clinical

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outcome.

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To our knowledge, this is the first report to include a large number of RSSM cases. However, further studies and more data are needed to better analyze this new procedure in terms of benefits and costs compared with

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multi-site robotic and conventional laparoscopic approaches.

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Figures

2 Fig. 1. The uterine myomas were removed by cutting and cauterizing with bipolar forceps and monopolar hook.

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Fig. 2. The uterine wall layers were sutured layer by layer with wristed needle driver.

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Fig. 3. The excised myoma nodules were pulled down in extralarge endobag with assistance of bipolar forceps

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and wristed needle driver bilaterally.

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Fig. 4. Surgical outcomes according to the period which RSSM was performed

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Tables

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Table 1. Statistical analysis of patient and leiomyoma character

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Table 2. Surgical outcomes.

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Table 3. Comparison of surgical outcome depending on types of leiomyoma

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Table 4. Comparison of surgical outcome depending on size of leiomyoma

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Table 5. Comparison of surgical outcome depending on period of RSSM done

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Obstet Gynecol 2009 Dec;201(6):566.e1-5

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7. Gobern JM, Rosemeyer CJ, Barter JF, Steren AJ. Comparison of Robotic, Laparoscopic, and Abdominal

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Myomectomy in a Community Hospital. JSLS. 2013 Jan-Mar;17(1):116-120

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8. Holloway RW, Patel SD, Ahmad S. Robotic surgery in gynecology. Scand J Surg 2009;98(2):96-109

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9. Alexander M. Quaas, MD, PhD, Jon I. Einarsson, MD, MPH, Serene Srouji, MD, Antonio R. Gargiulo, MD.

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Robotic Myomectomy : A Review of Indications and Techniques. Rev Obstet Gynecol. 2010 Fall;3(4):185-91.

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10. Gargiulo AR. Computer-assisted reproductive surgery: why it matters to reproductive endocrinology and

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infertility subspecialists. Fertil Steril 2014 Oct;102(4):911–21.

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11. Liu H, Lu D, Wang L, Shi G, Song H, Clarke J. Robotic conventional laparoscopic surgery for benign

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gynecological disease. Cochrane Database Syst Rev 2012:CD008978.

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12. Eisenberg D, Vidovszky TJ, Lau J, Guiroy B, Rivas H. Comparison of robotic and laparoendoscopic single-

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site surgery systems in a suturing and knot tying task. Surg Endosc 2013 Sep;27(9):3182–6.

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13. Nam EJ, Kim SW, Lee M, Yim GW, Paek JH, Lee SH, et al. Robotic single-port transumbilical total

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hysterectomy: a pilot study. J Gynecol Oncol 2011 Jun 30;22(2):120–6.

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14. Escobar PF, Knight J, Rao S, Weinberg L. Da Vinci single-site platform: anthropometrical, docking and

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suturing consideration for hysterectomy in the cadaver model. Int J Med Robot 2012 Jun;8(2):191–5.

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15. Lewis EI, Srouji SS, Gargiulo AR. Robotic single-site myomectomy: initial report and technique. Fertil

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Steril. 2015 May;103(5):1370-7.

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16. Ritter, F. E., & Schooler, L. J. The learning curve. In International Encyclopedia of the Social and

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Behavioral Sciences (2002), 8602-8605. Amsterdam: Pergamon

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17.Balachandran B, Hufford TA, Mustafa T, Kochar K, Sulo S, Khorsand. A Comparative Study of Outcomes

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Care Center. World J Surg. 2017 Jan 5. DOI: 10.1007/s00268-016-3799-0 (in press).

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18. Harr JN, Juo YY, Luka S, Agarwal S, Brody F, Obias V. Incisional and port-site hernias following robotic

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colorectal surgery. Surg Endosc. 2016 ;30:3505-10.

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19. Singal R, Zaman M, Mittal A, Singal S, Sandhu K, Mittal A. No Need of Fascia Closure to Reduce Trocar

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Site Hernia Rate in Laparoscopic Surgery: A Prospective Study of 200 Non-Obese Patients. Gastroenterology

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Res. 2016;9:70-3.

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20. Flyckt RL, Falcone T. Uterine Rupture After Laparoscopic Myomectomy. J Minim Invasive Gynecol. 2015

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Sep-Oct;22(6):921-2

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Between Robotic-Assisted, Single-Site Laparoscopy Versus Laparoendoscopic Single Site for Benign

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Hysterectomy. J Minim Invasive Gynecol. 2016 Jan;23(1):84-8.

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22. Scheib SA, Fader AN. Gynecologic robotic laparoendoscopic single-site surgery: prospective analysis of

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feasibility, safety, and technique. Am J Obstet Gynecol 2015 Feb;212(2):179.e1-8.

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ACCEPTED MANUSCRIPT Table. 1. Statistical analysis of patient and leiomyoma character

37.10 ± 5.82 (27-48)

Body mass index (kg/m2)

22.29 ± 4.05 (17.63-38.00)

History of abdominal surgery, n(%)

16 (26.2)

Leiomyoma 12 (1-12)

Size of largest (cm)

6.73 ± 2.04 (3.00-12.80)

Location within uterus, n(%) 24 (39.3)

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Anterior Posterior

22 (36.1)

Fundal

4 ( 6.5)

Anterior-Posterior

9 (14.8)

1 ( 1.6)

Whole

1 ( 1.6)

Type of leiomyoma, n(%)

40 (65.6)

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Subserosal

Intramural-Subserosal

15 (24.6) 2 ( 3.3) 4 ( 6.5)

Parity, n (%) 0

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Maximum number

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Age (y)

34 (55.7)

1

14 (23.0)

2

12 (19.7)

3

1 ( 1.6)

ACCEPTED MANUSCRIPT Table 2. Surgical outcomes.

Median IQR(Q1, Q3)

Docking time (min)

5.45 ± 2.84 (2.00-12.00)

3.92 IQR(3.00, 7.00)

Total operation time (min)

135.98 ± 59.62 (60-295)

110.00 IQR(90.00, 140.00)

Estimated blood loss (mL)

182.62 ± 153.02 (10-600)

Incision size (cm)

2.73 ± 0.28 (2.40-4.00)

Postoperative gas passing time (hr)

28.71 ± 12.99 (3.33-76.50)

Hospitalization period (Day)

4.21 ± 0.84 (3-6)

Transfusion rates, n(%)

2 (3.3%)

Hemoglobin change (g/dL)

2.43 ± 0.87 (1.20-5.20)

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Mean ± SD (Range)

2.70 IQR(2.50, 2.90)

24.88 IQR(20.88, 39.50)

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150.00 IQR(50.00, 300.00)

4.00 IQR(4.00, 5.00)

2.2 IQR(1.78, 2.90)

ACCEPTED MANUSCRIPT Table. 3. Comparison of surgical outcome depending on types of leiomyoma

Total

Estimated

Postoperative

operation

blood loss

gas passing

time (min)

(mL)

time (hr)

Average Type

N

40

97.50 ± 2.12

210.00 ± 268.70

15.59 ± 10.02

6.25 ± 3.04

140.25 ± 64.97

195.25 ± 156.63

30.98 ± 13.99

6.38 ± 1.81

[117.50,

[150.00,

[28.84,

[6.36,

IQR(91.25,168.75)]

IQR(50.00, 300.00)]

IQR(21.00,39.50)]

178.75 ± 52.66

162.50 ± 94.65

[175.00,

[125.00,

IQR(130.00,231.25)]

Intramural, 4 Subserosal

118.33 ± 41.95 Subserosal

15

[105.00, IQR(80.00,150.00)] .178

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IQR(5.30,7.30)]

24.94 ± 11.60

6.39 ± 1.05

[19.29,

[6.42,

IQR(100.00,262.50)]

IQR(18.89,36.62)]

IQR(5.35,7.39)]

150.67 ± 152.20

25.43 ± 9.36

7.80 ± 2.51

[100.00,

[23.0,

[7.3,

IQR(50.00,200.00)]

IQR(18.17,30.17)]

IQR(5.9,8.86)]

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Intramural

2

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Intraligamentary

RI PT

size (cm)

.755

.164

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ACCEPTED MANUSCRIPT Table 4. Comparison of surgical outcome depending on size of leiomyoma P-value < 6cm

6-10cm

>10cm

(KruskalWallis)

31

5

4.99 ± 0.79

7.33 ± 0.90

11.66 ± 0.99

[5.1,

[7.30,

[12.00,

IQR(4.80,5.52)]

IQR(6.60,7.82)]

IQR(10.70,12.45)]

2.32 ± 1.84

1.58 ± 0.89

3.8 ± 4.66

[2.00,

[1.00,

IQR(1.00,3.00)]

IQR(1.00,2.00)]

5.73 ± 3.07

5.37 ± 2.73

[5.00,

[5.00,

[3.67,

IQR(3.00,8.00)]

IQR(3.17,7.00)]

IQR(2.56,6.96)]

132.40 ± 60.57

137.6 ± 61.30

144.00 ± 54.24

[110.00,

[120.0,

[120.00,

IQR(87.50,175.00)]

IQR(90.0,150.0)]

IQR(97.50,202.50)]

Myoma average

Myoma average

Total operation

256.00 ± 215.48

[80.00,

[150.00,

[200.00,

IQR(50.00,190.00)]

IQR(100.00,300.00)]

IQR(90.00,450.00)]

29.86 ± 16.32

26.91 ± 10.19

34.13 ± 9.31

[24.75,

[24.33,

[38.25,

IQR(19.75,40.34)]

IQR(18.83,34.58)]

IQR(24.96,41.25)]

4.32 ± 0.90

4.06 ± 0.73

4.60 ± 1.14

[4.00,

[4.00,

[5.00,

IQR(4.00,5.00)]

IQR(4.00,5.00)]

IQR(3.50,5.50)]

2.71 ± 0.20

2.77 ± 0.34

2.60 ± 0.14

[2.60,

[2.70,

[2.60,

IQR(2.50,2.90)]

IQR(2.50,2.95)]

IQR(2.50,2.60)]

EP

AC C

passing (hr)

.226

4.4 ± 2.50

210.97 ± 157.72

loss (mL)

.000

IQR(1.00,7.50)]

132.80 ± 122.32 Estimated blood

Postoperative gas

TE D

time (min)

[2.00,

M AN U

number / op

SC

size (cm)

Docking time (min)

RI PT

25

N

.814

.760

.078*

.384

Hospitalization

.395

period (day)

Incision size (cm)

*

P for trend = 0.038 using linear regression analysis for log10 based EBL

.741

ACCEPTED MANUSCRIPT Table 5. Comparison of surgical outcome depending on period of RSSM done P-value 201411-201505

201506-201511

201512-201605 (Kruskal-Wallis)

14

N

30

17

6.49 ± 1.91

6.46 ± 1.90

[7.00,

[6.09,

[6.31,

IQR(5.20,8.08)]

IQR(5.15,7.27)]

IQR(5.30,8.41)]

2.00 ± 1.04

2.3 ± 2.45

1.71 ± 1.21

[2.00,

[1.00,

[1.00,

IQR(1.00,3.25)]

IQR(1.00,2.50)]

6.14 ± 3.15

6.08 ± 2.85

[4.75,

[7.00,

[3.00,

IQR(2.91,8.25)]

IQR(3.67,8.00)]

IQR(2.50,5.00)]

177.14 ± 77.95

135.33 ± 51.24

103.24 ± 31.82

[192.50,

[110.00,

[105.00,

IQR(105.00,277.50)]

IQR(90.00,137.50)]

IQR(80.00,135.00)]

189.29 ± 144.35

189.67 ± 165.89

164.71 ± 143.27

[200.00,

[150.00,

[150.00,

IQR(87.50,375.00)]

IQR(50.00,325.00)]

IQR(50.00,300.00)]

26.08 ± 9.95

30.17 ± 15.83

28.31 ± 9.38

[22.00,

[25.17,

[27.00,

IQR(18.58,27.95)]

IQR(22.49,40.67)]

IQR(20.00,39.50)]

4.71 ± 0.61

4.2 ± 0.92

3.82 ± 0.64

[5.00,

[4.00,

[4.00,

IQR(4.00,5.00)]

IQR(3.50,5.00)]

IQR(3.00,4.00)]

2.75 ± 0.62

2.69 ± 0.22

2.77 ± 0.13

[2.50,

[2.60,

[2.70,

IQR(2.48,2.95)]

IQR(2.50,3.00)]

IQR(2.70,2.90)]

(cm)

Docking time(min)

Total operation

Estimated blood

Postoperative gas

AC C

passing(hr)

EP

loss(mL)

TE D

time(min)

.550

IQR(1.00,2.00)] 3.79 ± 1.84

M AN U

number/op

.320

SC

Myoma average

RI PT

7.58 ± 2.39 Myoma average size

.006*

.009*

.724

.682

Hospitalization

.008

period(Day)

Incision size(cm)

*

P for trend = 0.011 using linear regression analysis for log10 based Docking time

*

P for trend = 0.001 using linear regression analysis for log10 based Total operation time

.046

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Precis : RSS myomectomy is safe and feasible technique.