Solo Surgeon Single-Port Laparoscopic Surgery With a Homemade Laparoscope-Anchored Instrument System in Benign Gynecologic Diseases

Accepted Manuscript Solo surgeon single-port laparoscopic surgery with a homemade laparoscopeanchored instrument system in benign gynecologic diseases Yun Seok Yang, MD, PhD Seung Hyun Kim, MD Chan Hee Jin, MD Kwoan Young Oh, MD, PhD Myung Haeng Hur, PhD Soo Young Kim, MD, PhD Hyun Soon Yim, MD, PhD PII:

S1553-4650(14)00057-0

DOI:

10.1016/j.jmig.2014.02.001

Reference:

JMIG 2249

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 10 July 2013 Revised Date:

25 January 2014

Accepted Date: 1 February 2014

Please cite this article as: Yang YS, Kim SH, Jin CH, Oh KY, Hur MH, Kim SY, Yim HS, Solo surgeon single-port laparoscopic surgery with a homemade laparoscope-anchored instrument system in benign gynecologic diseases, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/ j.jmig.2014.02.001. 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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Précis: We introduced a novel homemade laparoscope-anchored instrument system, and this system permits SPLS to be performed by a solo surgeon and obviates the need for a

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laparoscopic assistant. Paper is summarized as follows: This study aimed to present the initial operative experience of

solo surgeon single-port laparoscopic surgery (solo surgeon-SPLS) in the laparoscopic treatment of benign gynecologic diseases and to investigate its feasibility and surgical outcomes. SPLS has been constantly improving and evolving as a type of minimally invasive surgery for various diseases. However, SPLS has not fully replaced conventional laparoscopy. The real challenge of SPLS is to avoid interference between the operative instruments and the laparoscope. SPLS also requires significant coordination between the operating surgeon and the assistant who holds the laparoscope.

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In an attempt to resolve these problems and to allow the operating surgeon to have direct control of the operative field, a novel set of robotic instruments, termed the “da Vinci SingleSite” instruments, has been developed specifically for SPLS. However, the large size and high cost of the da Vinci kit will limit its uptake among surgeons. Another recent innovation in this area has been reported to be the magnetic instrumentation and robotic system for SPLS. While these innovations might improve the range of instrumentation and eliminate the need for a camera-driving assistant, all of the limitations of SPLS will still not be overcome. The reproducibility of safe operations within a cost-effective paradigm is also important. Additionally, these pilot studies are limited to animal models or a dry laboratory. We have taken a different approach to this problem through the development of a novel homemade laparoscope-anchored instrument system that consists of a laparoscopic instrument attached to a laparoscope and a glove-wound retractor umbilical port. This system permits SPLS to be performed by a solo surgeon and obviates the need for a laparoscopic assistant. We performed solo surgeon-SPLS in 13 patients between March 2011 and June 2012. For widespread adoption of the solo surgeon-SPLS, purpose-built modifications in our design are needed to develop a more robust laparoscope anchored instrument system using engineering innovations. Ultimately, this technological development may allow realization of the concept of solo surgeon-SPLS.

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Solo surgeon single-port laparoscopic surgery with a homemade laparoscope-anchored

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instrument system in benign gynecologic diseases

Yun Seok Yang, MD, PhD*, Seung Hyun Kim, MD, Chan Hee Jin, MD, Kwoan Young Oh, MD, PhD, Myung Haeng Hur, PhD, Soo Young Kim, MD, PhD, and Hyun Soon Yim, MD,

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PhD

From the Department of Obstetrics and Gynecology (YS Yang, SH Kim, CH Jin, and KY

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Oh), Departments of Nursing (MH, Hur), Departments of Preventive Medicine (SY, Kim). the Research Institute of IT Convergence Medicine (YS Yang, HS Yim, MH Hur , and SY Kim), Eulji University, and Yim Hyun Soon Obstetrics and Gynecology Clinic (HS Yim),

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Daejeon, Korea.

Précis: We introduced a novel homemade laparoscope-anchored instrument system, and this system permits SPLS to be performed by a solo surgeon and obviates the need for a

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laparoscopic assistant.

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Corresponding author: Yun Seok Yang, MD, PhD, Department of Obstetrics and Gynecology, Eulji University Hospital, Eulji University, 1306 Doonsan-dong, Daejeon 302120, Korea.

Tel: 82-42-611-3293, Fax: 82-42-611-3379, E-mail: [email protected]

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The authors have no commercial, proprietary, or financial interest in the products or companies described in this article.

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ABSTRACT This study aimed to present the initial operative experience of solo surgeon single-port laparoscopic surgery (solo surgeon-SPLS) in the laparoscopic treatment of benign gynecologic diseases and to investigate its feasibility and surgical outcomes. Using a novel homemade laparoscope-anchored

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instrument system that consisted of a laparoscopic instrument attached to a laparoscope and a glove– wound retractor umbilical port, we performed solo surgeon-SPLS in 13 patients between March 2011

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and June 2012. Intraoperative complications and postoperative surgical outcomes were measured. The main operative procedures performed were unilateral salpingo-oophorectomy (n = 5), unilateral salpingectomy (n = 2), adhesiolysis (n = 1), and laparoscopically assisted vaginal hysterectomy (n = 5). Additional surgical procedures included additional adhesiolysis (n = 4) and ovarian drilling (n = 1).The primary indications for surgery included 5 benign ovarian tumors, 2 ectopic pregnancy, 1

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pelvic adhesion (infertility), and 5 benign uterine tumors. The solo surgeon-SPLS was successfully accomplished in all procedures without a laparoscopic assistant. There were no intraoperative or postoperative complications. Our laparoscope-anchored instrument system obviates the need for an

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additional laparoscopic assistant, and allows SPLS to be performed by a solo surgeon. The findings show that with our system, solo surgeon-SPLS is a feasible and safe alternative technique for the

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treatment of properly selected patients with benign gynecologic diseases.

Keywords: Solo surgeon; single-port laparoscopic surgery (SPLS); benign gynecologic disease

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In recent years, single-port laparoscopic surgery (SPLS) has been reported as a technique for treating various gynecologic diseases [1–3]. Although revolutionary new instruments and ports have been designed, there are still technical difficulties in using a single port. Several

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approaches have been used to attempt to address these shortcomings, including flexible laparoscopes and articulated instruments that “bend away” from the midline, creating a degree of triangulation. However, these tools themselves present their own technical

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challenges and may not be widely available. The real challenge of SPLS is to avoid

interference between the operative instruments and the laparoscope. SPLS also requires

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significant coordination between the operating surgeon and the assistant who holds the laparoscope. An understanding between the operating surgeon and the laparoscope assistant is essential because every movement of one can interfere with the movements of the other. Therefore, this surgery requires a skilled surgeon and operating team. In an attempt to address these problems, Intuitive Surgical (Sunnyvalle, CA, USA) recently launched its da Vinci

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Single-Site kit, and initial clinical results have been reported with this system [4–6]. However, enhanced dexterity, in terms of instrumentation tip maneuverability, remains unresolved, and the large size and high cost of the da Vinci kit will limit its uptake among

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surgeons. The most recent innovation in this area has been reported to be the magnetic instrumentation and robotic system for SPLS [7–10]. These reports showed that further

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investigations are needed to develop the magnetic instrumentation and robotic systems capable of generating solo surgeon-SPLS. While these innovations might improve the range of instrumentation and eliminate the need for a camera-driving assistant, all of the limitations of SPLS will still not be overcome. Additionally, these pilot studies are limited to animal models or a dry laboratory. Therefore, many SPLS procedures rely only on standard off-the3

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shelf instrumentation [11]. Achieving proficiency with SPLS seems to be more challenging, as it requires higher level of laparoscopic skill [12] and operating team. We have taken a different approach to this problem through the development of a novel

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homemade laparoscope-anchored instrument system that consists of a laparoscopic

instrument attached to a laparoscope and a glove-wound retractor umbilical port. This system permits SPLS to be performed by a solo surgeon and obviates the need for a laparoscopic

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assistant.

This study aimed to present the initial operative experience of solo surgeon-SPLS, using

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feasibility and surgical outcomes.

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our system in the laparoscopic treatment of benign gynecologic diseases and to investigate its

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Materials and Methods

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Patients

SPLS was introduced for gynecologic tumors (author YSY) in November of 2010

subsequently utilizing this exclusively for all patients with symptomatic gynecological benign tumors. Prior to the start of this study, the surgeon performed three solo surgeon-SPLS for

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LAVH using the homemade laparoscope-anchored instrument system and with arbitrary

selection amongst the candidates of SPLS, which gave him some experience in manipulating

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the solo surgeon-SPLS. All of the procedures for SPLS and solo surgeon-SPLS were performed by the same surgeon (author YSY), who had experience of over 100 SPLS since November of 2010. Beginning in March 2011, solo surgeon-SPLS with an improvised homemade laparoscope-anchored instrument system was performed by the same gynecologic

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surgeon. Before the procedures, all patients were fully informed of the characteristics of SPLS and the possibility of requiring conversion to an open procedure or conventional laparoscopic surgery. SPLS were performed in patients with benign gynecologic diseases

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documented by results from ultrasound examinations, and who fulfilled the inclusion criteria, which included no history of pelvic inflammatory disease or medical illness. From the patients

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giving informed written consent for SPLS for LAVH or adnexal surgery, women were selected for solo surgeon-SPLS during the study period based on the anticipated ease in performing solo surgeonSPLS. We considered solo surgeon- SPLS appropriate for procedures that required removal of an entire mass, such as oophorectomy, salpingectomy, adhesiolysis, or LAVH. Women with severe adhesions, a fixed uterus, and strong pelvic adhesions were excluded from this study.

In this study,

13 patients underwent solo surgeon-SPLS between March 2011 and June 2012. Five of which 5

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had solo surgeon-SPLS for LAVH and eight patients had solo surgeon-SPLS for adnexal surgeries. During the same period, ninety-three patients underwent SPLS: 45 patients underwent SPLS for LAVH and 48 patients had SPLS for adnexal surgeries. This study was

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approved by the Institutional Review Board of Eulji University Hospital. Solo surgeon-SPLS was performed in selected cases, such as benign uterine diseases, tubal ectopic pregnancy,

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infertility, and benign adnexal tumors smaller than 8 cm in diameter.

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Operative Technique

The patients were administrated general anesthesia, placed in the lithotomy, and then Trendelenburg position. The surgeons stood between the patient’s left shoulder and the head side of the patient in order to benefit from maintaining a visual-motor alignment. After

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preparing and draping the patient, a single 15–20-mm transverse umbilical skin incision and a 1.5–2-cm rectus fasciotomy were made. The incision in the fascia was then extended with the scalpel, allowing a 2.5-cm access to the abdomen without extending the skin incision. For

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solo surgeon-SPLS, a novel homemade laparoscope-anchored instrument system was made, which is designed to avoid interference between the operative instruments and the

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laparoscope, and to maintain pneumoperitoneum (Fig. 1). This improvised system is comprised of the following 2 components: the umbilical port component, consisting of the Alexis wound retractor and a surgical glove, and the instrument component, consisting of the laparoscopic instrument attached to a laparoscope. In order to make the umbilical-port component, an Alexis wound retractor (Applied Medical, Rancho Santa Margarita, CA) was inserted transumbilically, and the outer rim was draped with a surgical glove into which one 6

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10-mm and one 5-mm cannula were inserted through the fingers of the glove. With the intention of making the instrument component, the laparoscope and the toothed grasper were inserted separately through each cannula of the umbilical port, and then both instruments

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were tied together with surgical gauze. The most obvious reason for deploying such

instruments is to obviate the need for a laparoscopic assistant. The operating surgeon controls the laparoscopic instrument attached to the laparoscope with one hand. At the same time,

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other laparoscopic instruments, inserted through another cannula, are used to transect or

dissect the tissue with the other hand. These instruments can be also inserted through cut

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edges of remained finger tips without trocar or cannula and tied with elastic bandage. Such a strategy allows the surgeon to control the visualization of the operative field and, simultaneously, to grasp and pull the tissue (Fig. 2). Each procedure was similar to the procedure performed by conventional laparoscopic surgery. We used a 30°, 10-mm rigid laparoscope during the study. Each SPLS procedure was performed with conventional, rigid,

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straight instruments in the same fashion as multiport laparoscopic surgery. The energy source was a monopolar electrocoagulation (Valleylab Force 2 electrosurgical unit, Valleylab, Boulder, CO, USA) or a 5–10-mm LigaSure vessel sealing system (Covidien, Valleylab,

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Boulder, CO, USA). Carbon dioxide was insufflated to maintain an intra-abdominal pressure of 10–12 mmHg, depending on the age and condition of the patient. After all procedures were

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completed, the abdominal cavity was given a final inspection for hemostasis and adjacent organ injury. We have used drainage tubes in all laparoscopic surgeries, including single and multiport laparoscopic surgeries. After the pelvic cavity was checked for bleeding, a transumbilical

drainage tube was inserted into the pelvic cavity for drainage of possible postoperative bleeding in patients who wished to preserve their fertility. We hypothesized that the 7

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accumulation of large volumes of bloody discharge could potentially create adhesions that likely would interfere with future pregnancies. We also inserted a drainage tube in patients where slight oozing of blood occurred after the operation. After the wound retractor was

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removed, the umbilical fascia and peritoneum were closed using no. 2 Polysorb (glycolidelactide copolymer) 5/8 suture (Covidien PLC, Dublin, Ireland). A subcuticular no. 2

MONOFIT-S (PGCL, Monofilament) suture (Ailee, Busan, Korea) was used for skin closure.

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The drainage tubes were routinely removed on postoperative day 2 if discharge was less than 50 mL/d

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or was nearly absent.

Statistical Analysis

All Solo surgeon-SPLS procedures have been documented in our database. The demographic and physical characteristics of the patients were obtained preoperatively. These

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data included the age, the height, weight, and the body mass index (BMI) of the patients, parity of the patients, and history of previous operations. Total operative times, indication for surgery, degree of inflammation, estimated blood loss (EBL), patient’s hemoglobin levels

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measured on postoperative day 1, amount of analgesic drugs used, and length of postoperative hospital stay were also obtained. Intra- and postoperative complications were

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recorded. All patients were followed for postoperative complications, such as hematoma formation in the incision site and infection, for 2 weeks after surgery in the outpatient department by the operating surgeon. After at least 3 months, patients were evaluated concerning cosmetic satisfaction, umbilical hernia, and any possible negative experiences. The Statistical Package for Social Sciences (SPSS, Chicago, IL, USA) was used to perform 8

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all statistical analyses. All data were analyzed and reported as the number (%) or median

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(range), and operative time are presented as the means ± standard deviation (SD).

Results

The characteristics of the patients and their operative procedures are listed in Table 1. Solo

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surgeon-SPLS for benign gynecologic diseases was successfully completed in 13 of 13

patients. The median age of the patients was 41 years (range 31–66 years), and the median

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body mass index was 24 kg/m2 (range 18–33 kg/m2). The median number of vaginal deliveries was 2 (range 0–4), and the percentage of previous abdominal surgery was 54% (7/13). The operative procedures included unilateral salpingo-oophorectomy (n = 5), unilateral salpingectomy (n = 2), adhesiolysis (n = 1), and LAVH (n = 5). Additional surgical procedures included additional adhesiolysis (n = 4) and additional ovarian drilling (n = 1).

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The primary indications for surgery included 5 benign ovarian tumors, 1 pelvic adhesion (infertility), 2 ectopic pregnancies, and 5 benign uterine tumors such as leiomyoma and

adenomyosis. The median adnexal tumor size was 7 cm (range 2-8 cm) and median uterine

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weight was 240 g (range, 111-572g). No intraoperative complications occurred, and there was no need for conversion to conventional laparoscopy. No blood transfusions were

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required. The mean operative time for patients having adnexal surgery or LAVH was 56.9 ± 15.8 min or 93 ± 9.75 min, respectively. The postoperative course was uneventful for all patients. The median postoperative hospital stay was 3 days (range, 2–4 day) for adnexal surgery and 4 days (range, 3–4 days) for LAVH. No postoperative complications were observed during follow-up.

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Discussion

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SPLS requires significant coordination between the surgeon and the assistant who holds

the laparoscope. If coordination between the surgeon and the laparoscopic assistant cannot be achieved, the ergonomics and feasibility of SPLS decreases. In an attempt to resolve these

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problems and to allow the operating surgeon to have direct control of the operative field, we constructed a novel homemade laparoscope-anchored instrument system, which offers simple

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and cost-effective access for procedures of the solo surgeon-SPLS. The results of this study showed that the solo surgeon-SPLS was safe, feasible, and suitable for extirpative gynecologic surgeries such as oophorectomy, salpingectomy, or LAVH, in our initial experience.

Laparoscopic surgery is challenging for both the surgeon and the assistant. The surgeon

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has no direct control over the viewing angle and an assistant without experience or an understanding of the surgeon’s needs for visualization can often provide erroneous views. All these ergonomic problems tend to disturb the surgeon’s concentration, causing fatigue and

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irritation, often to the detriment of the procedure. To overcome some of these difficulties, passive and robotic mechanical laparoscope holders have been designed and released over

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recent decades. Passive laparoscope holders such as the Endofreeze [13] (Aesculap AG, Tuttlingen,Germany), the Endoboy [14] (Geyser-Endobloc, Coudes, France), Martin Arm [15] (Gebrüder Martin GmbH & Co., Tuttlingen, Germany), the PASSIST [14] (Academic Medical Centre, Amsterdam, The Netherlands) are simple to use and offer good image stability for a low price. However, they may cause difficulty at critical points in the operation 10

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[16]. To overcome some of these difficulties, surgical robots have been produced such as the Endoassist (Armstrong Healthcare Ltd., High Wycombe, Buckinghamshire, United Kingdom)

[17], the FIPS endoarm (Karlsruhe Research Center, Karlsruhe, Germany) [18],

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the LapMan® (MedSys,Gembloux,Belgium) [19], the Naviot® (Hitachi Ltd., Tokyo, Japan) [20], and the Light Endoscope Robot (TIMC-MAG-CNRS laboratory, Grenoble, France)

[21,22]. Although active scope holders can improve the ergonomics of laparoscopy, there are

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numerous weaknesses in existing devices, and this combined with their expensive price in

comparison to cost-effective passive stands, tends to slow down their acceptance and use in

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hospitals [14]. These passive and robotic laparoscope holders could replace an assistant without changing the outcome of the procedure, allowing solo surgery to be performed in some simple cases. Furthermore, surgeons feel less fatigue and can concentrate better on their work, as they do not have to guide the assistant. Although these instruments may allow solo surgery using the multiport port to be performed, they have never been clinically validated

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for solo surgeon- SPLS, or even in SPLS. In the present study, the use of this novel homemade laparoscope-anchored instrument system is safe, feasible, and enables solo surgeon-SPLS to be performed. To our knowledge, our experience represents the first

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operative study performed by a solo surgeon for SPLS.

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The advantage of this technique is that the operating surgeon could directly control the operative field to his or her satisfaction (unlike the conventional SPLS system, in which the operating surgeon requires a laparoscope-holding assistant). Solo surgeon-SPLS with our system can be performed with minimal modifications of the current standard SPLS. Moreover, solo surgeon-SPLS can be easily converted to a SPLS or multiport conventional laparoscopic procedure at any time during the operation. Additionally, this system offers a 11

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practical, inexpensive, and reproducible method for solo surgeon-SPLS. Superior cosmesis is regarded as the main advantage in SPLS including solo surgeon-SPLS because the surgical wound is embedded within the umbilicus. However, superior cosmesis has not yet been

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validated. In addition, there are only few reports on improved “patient’s wound satisfaction” [23-25].Whether the intraumbilical scar is invisible or whether the umbilical aspect is

deteriorated by a 2–3 cm long (vertical) incision needs to be evaluated. Nevertheless, single

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port access such as solo surgeon-SPLS may improve cosmesis. The reproducibility of safe

operations within a cost-effective paradigm is also important. Our homemade laparoscope-

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anchored instrument system provides a simple, cost-effective approach to solo surgeon-SPLS. Various types of single-port devices such as the R-Port and the Uni-X single laparoscopic port system have now become commercially available. In our study, we used a homemade single port system consisting of a wound retractor, cannulas, and a surgical glove. This port system was designed to use existing instrumentation and easily accessible materials without the need for

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disposable trocars. Therefore, our homemade single port system is less expensive compared with the conventional R-port™ system (550,000 KRW for R-port™ versus 120,000 KRW for our port). The

hospital stay after solo surgeon-SPLS was much longer than that reported in the literature.

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The existing Korean fee-for-service payment system was in use at our hospital at that time. In Korea, most patients do not leave the hospital until they can return to normal activity. As

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results, the length of stay at our hospital in Korea may be different from that in other countries. Although solo surgeon-SPLS compared with SPLS, this was not assessed in the present study protocol. The mean operative time for SPLS for adnexal surgery was 72.6 ± 32.7 min and LAVH was 97.4 ± 24.9 min, respectively, and the median hospital stay with SPLS for adnexal surgery was 3 days (range, 2–4 days) and for LAVH was 4.6 days (range, 12

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3–6 days), respectively in our hospital data (not published). Therefore, the mean operative time and the median hospital stay of SPLS for adnexal surgery, and the mean operative time of SPLS for LAVH is similar to those reported for solo surgeon-SPLS in this study. The mean

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operative time for SPLS for adnexal surgery was approximately 25% longer than solo surgeon-SPLS (not statically significant). This suggests that more straight forward procedures should be chosen for patients requiring solo surgeon-SPLS. In other words, patients for solo surgeon-SPLS were selected

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by basing on anticipated ease in performing solo surgeon-SPLS. However, the median hospital

stay of patients receiving SPLS for LAVH is significantly longer than that reported in this

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study for solo surgeon-SPLS. These shorter hospital stays in cases of solo surgeon-SPLS for LAVH may be relevant in terms of potentially lower hospital costs related to nursing care, although this was not assessed in the present study protocol. As results, our homemade laparoscope-anchored instrument system provides a simple, cost-effective approach to solo surgeon-SPLS. However, further observation of a larger group of patients is required to

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ensure that these benefits persist. Proof of safety, the patient’s satisfaction with the procedure, cost and time saving, and the standardization and outcomes of solo surgeon-SPLS techniques should be investigated in further studies.

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A thick abdominal wall may significantly restrict trocar mobility at the access site and increase the distance between the umbilicus and the pelvic cavity, both leading to unfavorable

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instrument handling. It should be noted that all of our patients were Korean, with a median BMI of 24, which is less than typical for western women. Patients with a higher BMI are sometimes considered as “unsuitable” candidates for SPLS. When a fasciotomy is insufficient, a thick abdominal wall may significantly restrict instrument mobility at the access site during solo surgeon-SPLS. In our study, a sufficient fasciotomy was performed, and the solo surgeon-SPLS was successful in one obese patient with a BMI ≥ 30 kg/m². Solo 13

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surgeon-SPLS is possible with a sufficient fasciotomy even in women with a high BMI or in patients who have had previous abdominal operations. Although the initial experience of solo surgeon-SPLS is promising, experienced laparoscopic skills are essential for the safe and

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effective completion of this surgery. Solo surgeon-SPLS poses several challenges to

operating surgeons; the operative field is always parallel to the laparoscopic instrument

attached to a laparoscope (Fig. 2). Therefore, it requires superior hand-eye coordination and

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permits only restricted manipulation. Additionally, solo surgeon-SPLS may raise hurdles to some reconstructive procedures, such as repair after myomectomy and cystectomy.

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Therefore, improvements are needed to further develop applicable instruments and to adapt the technique.

The clinical limitations of this study include its limited number of patients, its noncomparative design. Another limitation is that the surgical outcomes of procedures performed by only 1 surgeon were analyzed. It is not clear whether this proficiency can be

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reproduced by other surgeons. This is a pilot study that can only access the feasibility and the safety of the procedure of solo surgeon-SPLS in this small group of patients before randomized controlled study can be performed to compare solo surgeon-SPLS with

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conventional SPLS. For widespread adoption of the solo surgeon-SPLS, purpose-built modifications in our design are needed to develop a more robust laparoscope anchored

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instrument system using engineering innovations. Ultimately, this technological development may allow realization of the concept of solo surgeon-SPLS. As with all new technologies, there will be an associated learning curve, and it will be incumbent on surgeons to develop new techniques by modifying traditional laparoscopic modalities. Further studies are required to prove that solo surgeon-SPLS can be performed with this 14

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developed laparoscope-anchored instrument system, or with current commercial instruments including the mechanical laparoscope holder, single port device, and 0-degree endoscope. Zero degree operating laparoscopes that take straight instruments are already available. An operative

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laparoscope with an operative port could be substituted while taking a 0 degree lens into

consideration. If various types of surgical instruments and appropriate ports are developed

and specified for solo surgeon SPLS, this surgery should be an alternative to the

widespread adoption of solo surgeon-SPLS more practical.

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conventional SPLS. We are hopeful that the development of this system may make

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In conclusion, our initial experience of solo surgeon-SPLS shows a safe and feasible procedure and we have described the required steps. Prospective, randomized, comparative controlled clinical studies are needed to confirm the relative advantages and disadvantages of

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solo surgeon-SPLS using this homemade laparoscope-anchored instrument system.

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new remote-controlled endoscope positioning system for endoscopic solo surgery. The FIPS endoarm. Surg Endosc. 2000 ;14:395-399. 19. Polet R, Donnez J.Gynecologic laparoscopic surgery with a palm-controlled laparoscope holder. J Am Assoc Gynecol Laparosc. 2004;11:73-78.

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20. Yasunaga T, Hashizume M, Kobayashi E, Tanoue K, Akahoshi T, Konishi K, Yamaguchi S, Kinjo N, Tomikawa M, Muragaki Y, Shimada M, Maehara Y, Dohi Y, Sakuma I, Miyamoto S. Remote-controlled laparoscopic manipulator system, Naviot™, for

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endoscopic surgery. Int Congr Se.r 2003;1256:678-683.

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Rambeaud JJ.Development of miniaturized light endoscope-holder robot for laparoscopic

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surgery. J Endourol. 2007;21:911-914.

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22. Jarry J, Moreau Gaudry A, Long JA, Chipon E, Cinquin P, Faucheron JL.Miniaturized robotic laparoscope-holder for rectopexy: first results of a prospective study. J Laparoendosc Adv Surg Tech A. 2013;23:351-355.

23. Aprea G, Coppola Bottazzi E, Guida F, Masone S, Persico G. Laparoendoscopic single site

Res. 2011;166:e109–112.

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(LESS) versus classic video-laparoscopic cholecystectomy: a randomized prospective study. J Surg

24. Lirici MM, Califano AD, Angelini P, Corcione F. Laparo-endoscopic single site cholecystectomy

2011;202:45–52.

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versus standard laparoscopic cholecystectomy: results of a pilot randomized trial. Am J Surg.

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25. Marks J, Tacchino R, Roberts K, et al. Prospective randomized controlled trial of traditional laparoscopic cholecystectomy versus single-incision laparoscopic cholecystectomy: report of preliminary data. Am J Surg. 2011;201:369–372.

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Figure legends

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Fig. 1 Homemade laparoscope-anchored instrument system for solo surgeon-SPLS. A: The umbilical port component, consisting of the Alexis wound retractor and a surgical glove,

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combined with the instrument component, consisting of the laparoscopic instrument attached to a laparoscope, in which both instruments were tied together with surgical gauze (white arrow). B: View of the position of this system during solo surgeon-SPLS. The laparoscopic instrument attached to a laparoscope (white arrow) and other laparoscopic instruments, such as a monopolar electrocoagulation (black arrow) and a suction instrument (transparent arrow). C, D: The movement of the laparoscopic instrument attached to a laparoscope (white arrow) 19

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and other laparoscopic instruments (black arrow) during solo surgeon-SPLS.

Fig. 2 Endoscopic view of the operative field during solo surgeon-SPLS for unilateral salpingo-oophorectomy (A, B) and LAVH (C, D). The operative field is always parallel to the laparoscopic instrument attached to a laparoscope (white arrow). However, this system

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permits surgeon to control the visualization of the operative field and simultaneously grasp and pull the tissue. The energy-source instrument, such as LigaSure (black arrow), is used to

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transect or dissect the tissue.

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Table 1 Patient characteristics and operative procedures (n=13)

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Age, median (range) 41 (31-66) BMI, kg/m2, median (range) 24 (18-33) History of vaginal delivery, median (range) 2 (0-4) % of previous abdominal surgery 54% (7/13) Main operation USO 5 Salpingectomy 2 Adhesiolysis 1 LAVH 5 Additional procedures additional adhesiolysis 4 additional ovarian drilling 1 Main cause Ovarian tumor 5 Pelvic adhension (infertility) 1 Ectopic pregnancy 2 Benign uterine tumor 5 Operative time (minutes), mean±SD 56.9 ± 15.8 Adnexal surgery LAVH 93 ± 9.75 Postoperative hospital stay, median (range) Adnexal surgery 3 (2-4) LAVH 4 (3-4) BMI = body mass index; USO = unilateral salpingo-oophorectomy; LAVH = laparoscopically assisted vaginal hysterectomy; SD = standard deviation