Feasibility of Reduced-Port Robotic Surgery for Myomectomy with the da Vinci Surgical System

Accepted Manuscript Feasibility of Reduced-Port Robotic Surgery for Myomectomy with the Da Vinci Surgical System

®

Jeong Jin Kim, M.D., Chahien Choi, M.D., Su Hyun Nam, M.D., Woo Young Kim, M.D., Ph.D. PII:

S1553-4650(17)30292-3

DOI:

10.1016/j.jmig.2017.04.025

Reference:

JMIG 3136

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 11 March 2017 Revised Date:

25 April 2017

Accepted Date: 30 April 2017

Please cite this article as: Kim JJ, Choi C, Nam SH, Kim WY, Feasibility of Reduced-Port Robotic ® Surgery for Myomectomy with the Da Vinci Surgical System, The Journal of Minimally Invasive Gynecology (2017), doi: 10.1016/j.jmig.2017.04.025. 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.

ACCEPTED MANUSCRIPT 1

Feasibility of Reduced-Port Robotic Surgery for Myomectomy with the Da Vinci®

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Surgical System

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Précis: Reduced-Port Robotic Surgery for Myomectomy using Octo-Port in our institution is

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feasible and safe surgery.

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Jeong Jin Kim, M.D., Chahien Choi, M.D., Su Hyun Nam, M.D., Woo Young Kim, M.D.,

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Ph.D.

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From the Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan

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University School of Medicine, Seoul, Republic of Korea (Drs. J. J. Kim, Choi, Nam, W. Y. Kim).

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Corresponding author: Woo Young Kim, M.D., Ph.D.

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Department of Obstetrics and Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University

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School of Medicine, 29 Saemunan-ro, Jongno-gu, Seoul 03181, Republic of Korea

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Tel: +82-2-2001-2499; Fax: +82-2-2001-1102; E-mail: [email protected]

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Disclosure: The authors declare no conflicts of interest.

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ACCEPTED MANUSCRIPT Abstract

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Study Objective: To present our initial experience with reduced port robotic surgery (RPRS)

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for myomectomy using Octo-Port.

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Design: Prospective and noncomparative study. (Canadian Task Force classification II-3).

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Setting: University hospital.

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Patients: Nineteen consecutive patients with symptomatic uterine fibroids desiring

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conservative minimally invasive robotic surgery from October 2015 to December 2016

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Interventions: An 8.5-mm or 12-mm robotic camera cannula was inserted through one of the

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Octo-Port channels and an 8-mm conventional robotic port was inserted into a 10-mm

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channel of the Octo-Port through a 3-cm trans-umbilical incision. An additional 8-mm

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conventional robotic port was inserted into a typical robotic port site in the patient’s right

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abdomen.

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Measurements and Main Results: Feasibility and operative outcomes of RPRS

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myomectomy.

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min) and 90 minutes (range, 29-198 min). The largest myoma was located on the anterior

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uterine wall in eleven patients (57.9%). The median myoma size and weight were 7.2 cm

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(range, 4.1-10.5 cm) and 141 g (range, 42-590 g), respectively. Median operative blood loss

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and change in hemoglobin were 100 mL (range 30-700 mL) and 2.6 mg/dL (range, 0.1-3.8

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mg/dL), respectively. The procedure were successfully performed via RPRS in 89.5 % of

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cases; two cases required placement of one to two additional robotic ports resulting in a

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return to traditional multiport robotic surgery. There were no major postoperative

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complications or postoperative hernias

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Conclusion: Our experience demonstrated the feasibility of RPRS for myomectomy using

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Octo-Port in selected patients.

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The median docking time and console time were 10 minutes (range, 4-22

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Key Words: Robotic myomectomy, Uterine fibroids, RPRS

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Introduction Uterine myomas are very common in women of childbearing age and clinically

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diagnosed in 20-50% of all women [1]. Laparoscopic myomectomy is an established

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alternative to standard transabdominal myomectomy for managing myomas, and is associated

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with several advantages including decreased postoperative incisional pain, shorter hospital

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stays, faster recovery time, and improved cosmetic satisfaction [2-5].

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The potential advantages of single-incision laparoscopic surgery (SILS) have recently

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been reported, and include improved cosmetic outcomes, decreased postoperative pain,

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reduced hemorrhage [6-8]. However, SILS myomectomy is not widely performed due to its

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technical difficulty. In particular, laparoscopic suturing of uterine wall defects is one of the

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most difficult and time-consuming tasks when performing SILS myomectomy.

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The Da Vinci Single-Site platform® (Intuitive Surgical, Sunnyvale, CA) was designed to

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overcome the shortcomings of SILS, and has been used to perform gynecologic operations,

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cholecystectomies, and some urological procedures [9-11]. However, the robotic single-site

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platform has several limitations, including reduced extracorporeal triangulation and a limited

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repertoire of non-articulating instruments and electrosurgical options compared with

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conventional multiport robotic surgery [12,13].

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RPRS, which refers to Single-Site platform® plus one conventional robotic port surgery,

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was introduced for left-sided colorectal cancer [14]. However, this approach is not widely

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used due to its limitations, including the absence of wrist function, as well as the limited

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range of motion of the semi-rigid robotic instruments [15].

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In order to achieve satisfactory cosmetic results and to resolve these problems, an

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alternative is the use of multi-port instruments, instead of semi-rigid single-port robotic

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instruments. In this study, we used the Octo-Port system (DalimSurgNet, Seoul, Korea)

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which is originally designed for SILS, thereby easily allowing us to perform RPRS for 4

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myomectomy using multiport instruments. Herein, we report our initial experience of RPRS

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for myomectomy.

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Materials and Methods

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Study design and participants

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This study, which was approved by the institutional review board, was designed as a

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prospective and noncomparative study. This study group included nineteen consecutive

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patients who underwent RPRS for myomas of uterus using the da Vinci surgical system

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(Intuitive Surgical, Sunnyvale, CA) at Kangbuk Samsung Hospital between October 2015

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and December 2016.

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Information regarding patient demographics was obtained from the KBSMC benign

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gynecologic disease database and included data regarding age, body mass index (BMI,

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kg/m2), parity, previous abdominal surgery, myoma characteristics (number, largest diameter,

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and location) and chief complaint. Myoma location was categorized according to

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International Federation of Gynecology and Obstetrics (FIGO) classification system.

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Perioperative details included docking time (to advance the robot to bedside and attach its

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arms to the trocars), console time (for the surgeon to perform the procedure at the console),

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surgery conversion, and any postoperative complications.

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Inclusion criteria were as follows: women with symptomatic myomas, such as

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menorrhagia, dysmenorrhea, or increased size; appropriate medical status for robotic surgery;

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and women between 19 and 50 years of age. Exclusion criteria were as follows: women with

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a dominant pedunculated subserosal myoma (FIGO classification type 7); women who had

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six or more myomas; women with the largest myoma >10 cm; women with any suggestion of

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malignant uterine or adnexal diseases.

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Preoperative evaluation of the size and location of myomas was performed using pelvic 5

ACCEPTED MANUSCRIPT magnetic resonance imaging, computed tomography or transvaginal sonography. Conversions

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were defined as follows: 1) addition of trocars or 2) conversion to laparotomy. Data on the

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intraoperative complications (defined as major vessel injury or injury to the bowels or urinary

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tract), and postoperative complications (defined as grade III or higher complications

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occurring within 30 days of surgery according to Clavien-Dindo classification [16]) were also

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collected.

Statistical analyses were performed with IBM SPSS 20.0 software (SPSS Inc., Chicago,

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IL, USA). The median (range) was used to describe the distribution of data after determining

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the normality of the data.

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Technique

All of the cases included in this study were performed by one surgeon. The participating

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physician (a gynecological oncology surgeon) began performing robotic surgery in June 2014

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and has considerable experience in single-incision laparoscopic surgery.

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Under general anesthesia, each patient was placed in the dorsal lithotomy position. At

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the start of surgery, an approximately 3-cm-sized vertical umbilical incision was made via an

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open Hasson approach. In all cases, before the Octo-Port was positioned at the incision, a 8.5-

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mm robotic cannula or 12-mm laparoscopic cannula was introduced through the 5-mm

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channel of the Octo-Port, and the cap component was removed. During this process, to

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prevent CO2 gas leakage, an iodine-impregnated incision drape (Ioban®) was used to cover

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the cannula and channel (Figure 1). After achieving pneumoperitoneum via insufflation of

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CO2 to 14mmHg, the patient was put in the Trendelenberg position at 20°. A 8.5-mm or 12-

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mm Da Vinci endoscope with a 0°-angled view was then inserted. An 8-mm conventional

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robotic port was inserted into the 10-mm channel of the Octo-Port. An additional 8-mm

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conventional robotic port for the Endowrist® system was inserted into a usual robotic port

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ACCEPTED MANUSCRIPT site on the patient’s right abdomen under direct visual observation. The robotic system’s

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patient-side cart was positioned centrally between the patient’ legs and docked at the camera

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port. The second assistant, positioning between the legs of the patient and patient-side cart,

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manipulated the uterine elevator to provide an effective surgical field.

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Before initiating the uterine incision, a local vasoconstrictor such as a dilute solution of

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vasopressin was injected into the myometrium to reduce blood loss. Using fenestrated bipolar

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forceps (Intuitive Surgical, Sunnyvale, CA) and Hot ShearsTM monopolar curved scissors, a

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hysterotomy was made over the myoma (Figure 2). The incision was made on a longitudinal

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or horizontal axis according the surgeon’s preference and patient condition. Layer-by-layer

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dissection was carried out to identify and enter the plane between the tumor pseudocapsule

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and the myoma itself. After identifying the cleavage plane, the myoma was enucleated by

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means of adequate traction with robotic tenaculum forcepes instead of robotic bipolar forceps.

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The bedside assistant provided additional traction on the myoma using a laparoscopic

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tenaculum forceps through the remaining trocar of the Octo-Port. Once removed, myomas

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were placed in the posterior cul-de-sac or in the paracolic gutter for retrieval and morcellation

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at the end of the surgery.

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The uterus incisions were repaired in one or two layer. Closure was performed using

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polyglyconate unindirectional barbed suture with a 37-mm half circle taper-point needle (V-

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Loc, Covidien) inserted through the 10-mm trocar of the Octo-Port. Typically, Hot ShearsTM

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monopolar curved scissors on the right arm were exchanged for the Mega SutureCutTM

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needle driver. The Mega SutureCutTM needle driver, with its high-force grip, was useful for

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minimizing needle movement during passage through the thick myometrium and facilitating

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closure on the defect.

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Prior to extraction of myomas from the abdomen, the robot-assist devices were

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undocked. The myomas, which were placed into the specimen retrieval endopouch, were 7

ACCEPTED MANUSCRIPT removed transumbilically with knife morcellation protected with a wound retractor that was

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connected to the Octo-Port system. Next, all operative sites were irrigated and any clots that

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had formed were removed. Once hemostasis was confirmed an adhesion barrier was placed

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over the uterine incision site. The peritoneum, fascia, and subcutaneous tissue were

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approximated and closed layer by layer with 2-0 Polysorb suture (Covidien), and skin

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adhesive (Liquibnad® , Advanded Medical Solution) was used to closed the incision.

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Results

During the study period a total of nineteen patients underwent RPRS for myomectomy

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using Octo-Port device. Indications for procedure included menorrhagia, dysmenorrhea, and

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increased myoma size. Details of 19 patients performed using RPRS are shown in Table 1.

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The baseline demographics of patients are tabulated in Table 2. The median age and

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BMI of the nineteen patients were 42 years (range, 31-48 years), and 22.2 kg/m2 (range, 17.1-

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34.1 kg/m2). Four of nineteen patients (21.1%) had prior abdominal surgery. The median size

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of the largest myoma was 7.2 cm (range, 4.1-10.5 cm). As revealed by magnetic resonance

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imaging, computed tomography or ultrasonography, the largest myoma was located on the

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anterior wall of the uterus in eleven patients (57.9%), and the posterior wall in the remaining

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patients.

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The median docking time and console time were 10 minutes (range, 4-22 min) and 90

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minutes (range, 29-198 min), respectively. The median count and weight of myomas were 4

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(range, 1-11), and 141 g (range, 42-590 g). Median operative blood loss and Hemoglobin

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change were 100 mL (range 30-700 mL) and 2.6 mg/dL (range, 0.1-3.8 mg/dL), respectively.

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The procedure was successfully performed via RPRS in 89.5% of cases; Patients 1 and 3

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required placement of additional robotic ports and were thus treated by traditional multiport

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robotic surgery. Conversion to laparotomy was not required in any of the cases. There were 8

ACCEPTED MANUSCRIPT no cases of inadvertent port removal due to vascular or visceral port injury, leakage of the

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pneumo-peritoneum, or bleeding at the intraoperative port site. There were no major

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postoperative complications, nor were there any cases of incisional or port-site hernia over

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the median follow-up period of five months (range, 1-9 months).

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Discussion

In this study, we prospectively collected and analyzed data pertaining to nineteen

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women, who underwent RPRS for myomectomy between October 2015 and December 2016.

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In our case series, PRPS with the Octo-Port had a success rate of 89.5 % with no cases of

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conversion to open laparotomy. A common feature in the two failure cases (Patients 1 and 3)

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was the location of myomas at the posterior wall of uterus, which made it relatively difficult

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to perform myomectomy. Thus, 17 patients had two wounds, one each at the umbilical site

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and the right abdomen da Vinci port site (Figure 3), while two patients had three wounds at

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the umbilical scar and the da Vinci port sites on the right and left abdomen. In no cases did

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the number of wounds exceed three, and was thus less than or equal to that of conventional

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robotic surgery. The two cases that were converted to conventional robotic surgery were early

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in the use of RPRS at our institution, and since then we have had no failure of RPRS. In

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addition, we noted significant progress in shortening docking time with increasing experience.

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Starting with the sixth case, we also began using robotic tenaculum forceps, which facilitated

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better enucleation of myomas compared with previous cases. This change may have

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contributed to the ease of success of RPRS for myomectomy.

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Previous robotic single-site platforms had several limitations, including a restrictive

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range of motion with non-articulating instruments and limited electrosurgical options

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compared with conventional robotic surgery. Thus, it has been considered quite a challenge

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to enucleate myomas and suture the incision site with the semi-curved, non-articulating 9

ACCEPTED MANUSCRIPT instruments. The instruments designed for use in robotic single site platforms are relatively

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more flexible than those of conventional robotic instruments, and are therefore unsuitable for

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surgeries where a firm grasp is needed, such as pulling and providing traction when

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enucleating myomas. Because the uterus is rather solid and firm compared to other internal

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organs, this issue needs to be considered in gynecologic surgery.

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RPRS for myomectomy using multiport instruments resolves many of the issues

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described above; however, there are several restrictions such as smoke evacuation which led

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to poor visibility in some cases. Specifically, because air-suction is connected to the Octo-

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Port, smoke particles can lead to decreased visibility in the pelvic cavity, increasing stress on

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the surgeon as well as prolonging the operating time [17]. In this study, use of a 12-mm

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robotic endoscope led to improved visibility, and thus may represent a provisional solution to

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this problem.

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Collision between the camera and surgical instruments is another problem faced by

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operators in all single site platform laparoscopic surgery. However, in RPRS with a skin

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incision diameter of about 30 mm, the operator can simultaneously use the left robotic

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instrument and instrument of an assistant, including an endoscope. In some circumstances,

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movement of the assistant instrument is not sufficient for surgical procedures, such as traction

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of myomas or evacuation of hematomas. To resolve this problem, robotic endosopes can be

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moved in the same direction as an assistant instrument.

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Despite the limitations discussed above, RPRS is a feasible method for suture-intensive

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procedures such as myomectomy. Specifically, the increased articulation and dexterity of the

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robotic instrument “wrist” of the left arm facilitated suturing and closure of uterine defects,

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and the movement of the right arm in additional ports was the same as that in multiport

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robotic surgery. In addition, because in-bag morcellation using a knife is possible through the

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3-cm diameter umbilical incision, there is an advantage to prevent dissemination of myoma 10

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fragments, which occurs when power morcellation devices are used. The present study demonstrates that the RPRS for myomectomy using Octo-Port plus an

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additional conventional robotic port can be performed with comparable operative outcomes.

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Before start of RPRS myomectomy, we have performed eight cases of conventional robot-

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assisted laparoscopic myomectomy in our center. Although it was not possible to statistically

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compare the two sets of patient data due to small group size, the operative outcomes,

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especially docking time, console time, and estimated blood loss, were comparable (Table 3).

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To the best of our knowledge, the present study represents the first application of RPRS

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for myomectomy using Octo-Port and conventional multiport robotic instruments. This

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procedure, as described, appears to be feasible and safe in selected patients. With respect to

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cosmetic outcomes, the benefits of RPRS myomectomy are obvious: four incisions are

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decreased to two. Moreover, our approach was able to overcome some of inherent limitations

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of robotic single-site surgery. We believe that further experience and technical refinements

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will continue to improve operative results. Large-cohort or randomized prospective studies

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with long-term follow-up are necessary to validate the best indications and safety profile of

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PRPS myomectomy.

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ACCEPTED MANUSCRIPT Figure Legends Fig. 1. Preoperative setting for RPRS using Octo-port. Fig. 2. RPRS setup with multiport robotic instruments

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Fig. 3. Wound of postoperative RPRS

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ACCEPTED MANUSCRIPT

Table 1

Location Docking Console BMI

of largest time

time

No.

Patient y

(kg/m2) Parity

myoma

(min.)

myomas (g)

1

21.8

Posterior 22

198

10

19.4

N

Anterior

3

46

22.2

P

4

41

20.9

5

42

6

20

146

1

Posterior 17

90

4

P

Posterior 11

44

24.5

P

Anterior

14

37

18.9

N

Anterior

18

7

44

21.7

P

Anterior

8

8

48

23.7

P

9

37

22.8

10

42

34.1

blood loss classification

Indications

(mg/dL)

(mL)

of myoma

Menorrhagia

0.1

700

2

(Transfusion)

158

Dysmenorrhea 3.5

500

3

90

Size increased 1.8

300

5

2

117

Menorrhagia

2.6

200

3

119

8

144

Dysmenorrhea 2.7

150

4

90

4

42

Menorrhagia

3.1

150

2

72

1

100

Menorrhagia

1.9

100

2

Posterior 7

37

3

100

Size increased 1.8

100

4

N

Anterior

8

94

4

97

Dysmenorrhea 1.3

100

5

N

Posterior 6

60

2

202

Size increased 1.7

80

4

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31

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2

200

hemoglobin

SC

N

Operative FIGO

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(min.)

of myomas

Change in

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Age,

Weight of

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Details of 19 patients performed using RPRS

ACCEPTED MANUSCRIPT

Anterior

12

48

23.6

N

13

38

24.4

14

44

15

107

6

235

Size increased 3.0

100

5

Posterior 9

84

4

141

Menorrhagia

100

5

N

Posterior 4

126

8

106

Dysmenorrhea 2.1

200

3

17.1

P

Anterior

14

51

1

357

Size increased 2.6

100

5

29

21.2

N

Anterior

5

83

9

210

Size increased 2.9

50

4

16

40

26.4

P

Anterior

6

75

2

590

Size increased 3.8

100

6

17

44

24.2

P

Anterior

14

155

11

430

Size increased 2.7

500

6

18

42

20.4

N

Anterior

8

101

2

73

Menorrhagia

200

0

19

34

19.9

N

Posterior 10

29

1

130

Size increased 2.5

30

3

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N = Nulliparous; P = Parous.

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2.4

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23.1

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ACCEPTED MANUSCRIPT Table 2 Patient characteristics. Results

Number of patients

19

Age (years), median (range)

42 (31-48)

Parity, median (range)

0 (0-2)

BMI (kg/m2), median (range)

22.2 (17.1-34.1)

SC

RI PT

Characteristics

Previous abdominal surgeries, n (%)

4 (21.1)

M AN U

Location of the largest myoma, n (%) Anterior

11 (57.9)

Posterior

8 (42.1)

AC C

EP

TE D

Size of the largest myoma (Cm), median (range)

7.2 (4.1-10.5)

ACCEPTED MANUSCRIPT Table 3 Operative outcomes of RPRS myomectomy and conventional robotic myomectomy. RPRS myomectomy Conventional robotic (n = 19)

myomectomy (n = 8)

Docking time (min), median (range)

10.0 (4-22)

12.5 (4-20)

Console time (min), median (range)

90.0 (29-198)

Conversion, n (%)

2 (10.5)

Hospital stay (day), median (range)

3 (3-5)

97.5 (37-170)

0

SC

3.5 (3-5)

200 (100-700)

Hb change, (mg/dL), median (range)

2.6 (0.1-3.8)

2.0 (1.1-6.9)

4 (1-11)

1.5 (1-8)

Weight of myomas (g), median (range)

141.0 (42-590)

181.0 (79-751)

Weight of myomas (g), average

185.4

234.0

AC C

EP

TE D

M AN U

Estimated blood loss (ml), median (range) 100 (30-700)

Count of myomas, median (range)

1

RI PT

Operative outcomes

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

Précis : Reduced-Port Robotic Surgery for Myomectomy using Octo-Port in our institution is feasible and safe surgery.