Barbed Suture vs Traditional Suture in Single-Port Total Laparoscopic Hysterectomy

Barbed Suture vs Traditional Suture in Single-Port Total Laparoscopic Hysterectomy

Accepted Manuscript Barbed suture versus traditional suture in single-port total laparoscopic hysterectomy Taejong Song, M.D. San-Hui Lee, M.D PII: ...

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Accepted Manuscript Barbed suture versus traditional suture in single-port total laparoscopic hysterectomy Taejong Song, M.D. San-Hui Lee, M.D

PII:

S1553-4650(14)00207-6

DOI:

10.1016/j.jmig.2014.03.012

Reference:

JMIG 2278

To appear in:

The Journal of Minimally Invasive Gynecology

Received Date: 26 December 2013 Revised Date:

4 March 2014

Accepted Date: 13 March 2014

Please cite this article as: Song T, Lee SH, Barbed suture versus traditional suture in single-port total laparoscopic hysterectomy, The Journal of Minimally Invasive Gynecology (2014), doi: 10.1016/ j.jmig.2014.03.012. 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

Barbed suture versus traditional suture in single-port total

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laparoscopic hysterectomy

3 Taejong Song, M.D., San-Hui Lee, M.D.

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Department of Obstetrics & Gynecology, CHA Gangnam Medical Center, CHA University,

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Seoul, Korea

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Department of Obstetrics & Gynecology, National Health Insurance Service Ilsan Hospital,

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Goyang, Korea

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*Corresponding author: San-Hui Lee, MD

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Department of Obstetrics and Gynecology, National Health Insurance Service Ilsan

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Hospital, 1232 Baekseok 1-dong, Ilsandong-gu, Goyang 410-719, Republic of Korea

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Tel: +82-31-900-0218; Fax: +82-31-900-0138; E-mail: [email protected]

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Conflict of interest: We have no conflicts of interest to declare.

Short version of title: Barbed suture in single-port TLH

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Précis: On the basis of our data, use of barbed suture in single-port TLH aided

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surgeons by reducing operative time, suturing time, and surgical difficulty.

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ACCEPTED MANUSCRIPT ABSTRACT

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Study Objective: The aim of this study was to compare surgical outcomes between

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barbed suture and traditional suture used in repair of the vaginal vault during single-

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port total laparoscopic hysterectomy (TLH).

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Design: Case-control study (Canadian Task Force Classification II-2).

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Setting: Two institutions.

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Patients: One hundred and two patients with benign uterine disease.

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Interventions: Single-port TLH with barbed suture (n=43) or traditional suture

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(n=59).

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Measurements and Main Results: Patient characteristics (age, body mass index,

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demographic data), procedures performed, uterine weight, and uterine pathologies

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were similar between the two study groups. There were also no differences in

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operative complications, conversion to other surgical approaches, operative blood

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loss, postoperative pain, and duration of hospital stay between the two groups. Use of

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barbed suture significantly reduced the amount of time required for vaginal cuff

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suturing (11.4 versus 22.5 min; P<0.001) as well as the total operative time (92.0

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versus 105.2 min; P=0.002). The use of barbed suture is less technically demanding

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compared with traditional suture (P<0.001).

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Conclusion: Use of barbed suture in single-port TLH may aid surgeons by reducing

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operative time, suturing time, and surgical difficulty.

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Keywords: barbed suture; V-Loc; hysterectomy; single-port.

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ACCEPTED MANUSCRIPT Introduction

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Total laparoscopic hysterectomy (TLH) is a well-established alternative to standard

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transabdominal hysterectomy for managing benign uterine disease, with the special

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advantages of less pain, shorter hospitalizations, earlier return to normal activities,

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and better cosmetic outcomes [1,2]. Recently, TLH using multiple trocars has been

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replaced by single-port (also known as laparoendoscopic single-site [LESS]) TLH in

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order to improve cosmetic results by reducing the number of incisions [3,4].

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However, single-port TLH has been not widely utilized due to its technical difficulty.

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In particular, laparoscopic suturing of the vaginal vault is one of the most difficult and

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time-consuming tasks performing during single-port TLH.

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Barbed suture is a new technology that has the potential to greatly facilitate

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laparoscopic suturing. One of these novel sutures, the V-Loc (Covidien, Mansfield,

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MA, USA) consists of an unidirectional barbed absorbable thread that is armed with a

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surgical needle at one end and a loop at the opposite end that is used to secure the

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suture. The barb and loop ends allow for approximation of the tissue without the need

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to tie surgical knot. Barbed suture has been used in a number of multi-port

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laparoscopic

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gastrointestinal anastomosis [8], colectomy [9], and hernia repair [10] with good

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results. To date, however, it has not been tested for single-port laparoscopy including

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single-port TLH. Therefore, the current study aimed to evaluate surgical outcomes in

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which barbed or traditional suture was used for repair of the vaginal vault during

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single-port TLH.

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Materials and Methods

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1. Study population

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[5,6],

hysterectomy

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ACCEPTED MANUSCRIPT This was a case-control study of 102 consecutive patients who underwent single-port

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TLH between January 2013 and October 2013 at two institutions (CHA Gangnam

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Medical Center, Seoul, Korea; National Health Insurance Service Ilsan Hospital,

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Goyang, Korea). The first 59 patients who underwent single-port TLH using

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traditional intracorporeal continuous suture were compared with the next 43 patients

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who underwent single-port TLH using an absorbable unidirectional knotless barbed

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suture for repair of the vaginal vault. All patients signed a written informed consent

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prior to the single-port TLH authorizing collection of data to be analyzed

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prospectively after approval by the Institutional Review Board.

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Inclusion criteria for this study were as follows: patients who had an indication for

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hysterectomy due to gynecologic disease, patients who had no evidence of

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gynecologic malignancy on imaging studies, and patients with an appropriate medical

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status for laparoscopic surgery (American Society of Anesthesiologists Physical

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Status classification 1 or 2). Major exclusion criteria were age ≤18 years, uterine size

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≥20 gestational weeks on pelvic examination, recent diagnosis of cancer, and inability

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to understand and provide written informed consent.

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2. Surgical procedures

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All procedures were performed by two surgeons (T. Song and S.H. Lee) who had each

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previously managed >200 single-port TLHs. All patients underwent the same standard

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preparation prior to surgery, including the administration of prophylactic antibiotics

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30 min before the procedure. The single-port TLH technique used has been previously

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described [11]. In brief, after the introduction of general anesthesia, a single multi-

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channel port was inserted through the umbilicus and a laparoscope was introduced

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through a one of the channels. While the uterine body was retracted medially with

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laparoscopic forceps or a myoma screw, the adnexal pedicle, round ligament, and

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ACCEPTED MANUSCRIPT broad ligament were transected with a LigaSure (Valleylab, Boulder, CO, USA).

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Next, the vesicouterine peritoneal fold was identified, and the bladder was mobilized

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by blunt and sharp dissection using the LigaSure until the anterior vagina was

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identified. The uterine vessels were skeletonized, sealed, and transected using the

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LigaSure or a bipolar electrical device. The cardinal and uterosacral ligaments were

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then transected. The procedure was then repeated on the opposite side. A

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circumferential colpotomy was performed using a monopolar electrical device or the

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LigaSure over the Colpotomizer cup. The specimen was removed via the vagina, and

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vaginal or laparoscopic uterine morcellation was performed if necessary.

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In the case group (barbed suture group), a vaginal cuff closure was achieved

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laparoscopically with a 30 cm 1-0 polyglyconate unidirectional barbed suture with a

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37 mm half-circle taper-point needle (V-LocTM 180; Covidien). The first suture was

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locked by a loop at the one end of the vaginal cuff (Fig. 1A), and then a continuous

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suture was passed though to the opposite end of the vaginal cuff and cut without tying

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a knot (Fig. 1B). The uterosacral ligaments were incorporated into the cuff closure to

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provide apical support. In the control group (traditional suture group), a vaginal cuff

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closure was performed in a single layer with Vicryl (Ethicon, Somerville, NJ, USA) or

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Monosyn (B-Brown, Tuttlingen, Germany) in a continuous manner using

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intracorporeal knots tying to secure each end of the suture. After bleeding was

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controlled, the single multi-channel port was removed, the transumbilical fascia and

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subcutaneous tissue were approximated and closed layer by layer with 1-0 Vicryl, and

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the skin was closed subcuticularly with 3-0 Vicryl.

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3. Data collection

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Personal history, age, body mass index (BMI), and clinical and diagnostic information

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about each patient's disease were collected in an electronic database at the time of

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ACCEPTED MANUSCRIPT recruitment. At the end of each procedure, intraoperative data including the operative

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time, estimated blood loss (evaluated as the balance between the aspirated and the

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irrigated liquid), intraoperative complications, and conversion to multi-port TLH,

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laparoscopic-assisted vaginal hysterectomy (LAVH), or laparotomy were recorded.

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The operative time was divided into three segments: the time from skin incision to the

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removal of a uterine specimen, the time for vaginal cuff suturing, and the time from

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completion of cuff closure to umbilical skin closure. The degree of surgical difficulty

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was also evaluated subjectively by the same operator using a visual analog scale

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(VAS) that ranged from 1 (low difficulty) to 10 (high difficulty). During the hospital

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stay, postoperative pain was evaluated in all patients using a VAS score of 0 to 10 (0,

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no pain; 10, agonizing pain). Postoperative complications were defined as adverse

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events arising within three months of surgery.

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4. Statistical analysis

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SPSS version 13.0 (SPSS, Inc., Chicago, IL, USA) was used for all statistical

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analyses. Data are presented as means ± SDs or medians (ranges) for quantitative

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variables, and frequencies (percentages) for qualitative variables. Baseline clinical

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characteristics and study outcomes between the two groups were compared using

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Student’s t-tests or Mann-Whitney tests for continuous variables, and χ2 tests or

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Fisher’s exact tests for categorical variables, as appropriate. A P-value <0.05 was

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considered to be statistically significant.

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Results

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Baseline demographic data including age, BMI, parity, menopausal status,

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comorbidities, abdominal surgical history, history of vaginal deliveries, and level of

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preoperative hemoglobin were similar between the two study groups (Table 1). The

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ACCEPTED MANUSCRIPT mean age and BMI of the study patients were 46.7 ± 7.4 years and 24.6 ± 4.3 kg/m2,

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respectively. Uterine pathology, the surgical procedure performed, and extracted

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uterine weight did not differ between the study groups (all P >0.05)

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In Table 2, surgical results were compared between the two groups. The mean

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operative time for the entire surgical procedure was shorter in the barbed suture group

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(92.0 ± 33.5 min) than in the traditional suture group (105.2 ± 31.4 min) (P=0.002).

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The mean time required for vaginal cuff suture was also shorter in the barbed suture

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group in comparison with the traditional suture group (11.4 ± 4.2 min versus 22.5 ±

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3.8 min; P <0.001). However, no differences were observed between groups in other

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different operative time segments such as the time from skin incision to the removal

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of the specimen or from the time of completion of cuff closure to umbilical skin

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closure. The degree of surgical difficulty was significantly lower in the barbed suture

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group than in the traditional suture group (P <0.001). Estimated blood loss and

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decreases in hemoglobin (defined as the difference between the preoperative

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hemoglobin level and that measured on postoperative day 1) were not significantly

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different between groups.

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In the traditional suture group, the intended single-port TLH failed in 8 of 59 cases

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(13.6%). Conversion to multi-port TLH was needed in a total of 6 cases because of

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difficulty in suturing the vaginal cuff (three cases) and the presence of a distorted

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lower uterine contour (three cases). Conversion to laparotomy was needed in two

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cases for adhesiolysis due to severe pelvic adhesions. In the barbed suture group, the

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failure of single-port TLH was observed in two cases (4.6%); conversion to multi-port

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TLH (one case) and single-port LAVH (one case) were needed due to a distorted

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lower uterine contour. The failure rate in the barbed suture group was lower than in

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the traditional suture group (4.6% versus 13.6%), though this difference did not reach

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ACCEPTED MANUSCRIPT statistical significance. No significant intraoperative complications or major

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postoperative complications were observed in either group. In both groups, minor

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postoperative complications occurred in four cases and were managed conservatively

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without any surgical, endoscopic, or radiologic intervention. No differences were

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observed between groups with respect to complication rates, VAS scores for

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postoperative pain, or length of hospital stay (defined as the time between surgery and

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discharge).

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180 Discussion

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In this study, we prospectively collected and analyzed data regarding the surgeon's

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experiences and the complications of single-port TLH in 102 consecutive patients.

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There was no difference in complication rates between the traditional suture group

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and the barbed suture group; however, the use of barbed suture was effective in

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reducing the time required for vaginal cuff suturing (thereby reducing the total

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operative time) and decreasing the surgical difficulty. As surgeons seek more time-

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and labor-effective surgical approaches, our results will benefit those interested in

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performing minimally invasive surgeries.

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Laparoscopic suturing is widely considered one of the most difficult and time-

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consuming tasks performed during laparoscopic surgery. The main reason for this is

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the need to tie knots in a confined space with limited visualization [12]. These

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limitations are even more pronounced in single-port laparoscopy. Therefore, to avoid

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the technical difficulty that accompanies intracorporeal suturing of the vaginal cuff

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during single-port hysterectomy, alternative methods have been utilized including

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transvaginal cuff suture [3,13] and intracorporeal suture with extracorporeal knots

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through the use of knot-pusher device [14]. In this study, we provide new evidence

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ACCEPTED MANUSCRIPT that intracorporeal vaginal cuff closure with barbed suture is simple and efficient for

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use in single-port TLH.

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In the present study, no major complications were observed. Regarding minor

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complications, there were only three cases (2.9%) of vaginal vault bleeding (two in

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the traditional suture group; one in the barbed suture group) and only one patient

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required a transfusion (traditional suture group). No differences were observed

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between groups in complication rates. This result was consistent with that of Nawfal

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et al. [15], in that there was no difference in complications between V-Loc suture and

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traditional suture during robotic-assisted TLH. Although no vaginal vault dehiscence

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occurred in our series, this is a major concern when using barbed suture. Drudi et al.

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[16] reported 7 cases of dehiscence encountered in 441 robotic-assisted TLHs. The

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vaginal vault closures in these 7 patients were performed using traditional suture

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(6/323, 1.9%) and unidirectional barbed suture (1/118, 0.8%); thus, the dehiscence

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was unrelated to the suture material used. Taken together, these finding suggest that

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the use of unidirectional barbed suture appears to be safe.

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As previously reported [5], the principal limitation to increasing the use of barbed

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suture is that it is more expensive than traditional suture; however, the reduction in

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surgical time may balance this cost. Our opinion is in line with results reported by

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Massoud et al. [17], who performed a cost-effectiveness analysis of robotic-assisted

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radical prostatectomy using unidirectional barbed suture, compared with the use of

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traditional suture, and found the former to be more economical.

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A major limitation of our study is its non-randomized nature and the comparisons

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made between data obtained during two different study periods. It is possible that

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surgical technique improved as the study period went on as well, which could

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potentially affect the results as evidenced by a "practice effect". However, the primary

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ACCEPTED MANUSCRIPT surgeons had extensive experience in performing single-port TLH before the start of

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this study; therefore, significant improvement in surgical technique is unlikely. In our

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series, no differences were observed between the two groups with respect to duration

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of operative time segments (the time from skin incision to the removal of a specimen

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and the time from completion of cuff closure to umbilical skin closure) except for the

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time of vaginal cuff suturing. In addition, this consecutive case series of vaginal cuff

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closures with barbed suture included the first cases in which this suture material was

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used, thereby incorporating a learning curve component. The other limitation of this

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study is the lack of long-term follow-up data. Although our data included women who

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had a minimum of three months of follow-up data, long-term outcomes for barbed

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suture should be assessed.

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In conclusion, there were no differences in complication rates between the traditional

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suture and barbed suture groups in our sample. However, the latter approach had a

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shorter operative time and was technically less difficult. A single-port approach is

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challenging for surgeons, and is required their skills and ambidexterity. On the basis

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of our own experience, we propose that barbed suture is a promising technique for

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vaginal cuff closure in single-port TLH.

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Acknowledgements

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The authors would like to thank Dr. Jisun Yon for her help with figure preparation.

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Facy O, De Blasi V, Goergen M, Arru L, De Magistris L, Azagra JS. Laparoscopic gastrointestinal anastomoses using knotless barbed sutures are

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Figure legend

299 Figure 1. Closing the vaginal cuff with unidirectional barbed suture.

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(A) Begin suturing in one end of the vaginal cuff, and (B) Perform a continuous

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suture to the opposite end and then cut the suture without a knot.

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ACCEPTED MANUSCRIPT Table 1 Baseline characteristics. Traditional suture (n=59) 46.1 ± 5.9 24.3 ± 4.3

Barbed suture (n=43) 47.8 ± 9.1 25.1 ± 4.4

P-value

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Age (years) 0.903 2 BMI (kg/m ) 0.268 Parity >0.999 Nulliparous 4 (6.8%) 3 (7.0%) Parous 55 (93.2%) 40 (93.0%) Menopause 4 (6.8%) 6 (12.2%) 0.507 History of abdominal surgery 19 (32.2%) 12 (27.9%) 0.670 History of vaginal delivery 41 (69.5%) 31 (72.1%) 0.776 Preoperative hemoglobin (mg/dL) 11.6 ± 1.9 11.9 ± 1.6 0.380 Uterine weight (g) 341 ± 195 299 ± 188 0.269 Primary pathology 0.758 Leiomyoma and/or adenomyosis 55 (93.2%) 39 (88.6%) Endometrial pathology 2 (3.4%) 2 (4.5%) Preinvasive cervical neoplasia 2 (3.4%) 3 (6.8%) Surgical procedure 0.661 TLH alone 43 (72.9%) 29 (67.4%) 16 (27.1%) 14 (32.6%) TLH with adnexal surgery a Adhesiolysis 19 (32.2%) 13 (30.2%) 0.832 Data are expressed as the mean ± standard deviation or frequency (proportion), as appropriate. BMI, body mass index; TLH, total laparoscopic hysterectomy. a Adnexal surgery includes ovarian cystectomy, salpingo-oophorectomy, and salpingectomy.

ACCEPTED MANUSCRIPT Table 2 Surgical results. Traditional suture (n=59)

Barbed suture (n=43)

P-value

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Operative time (min) Total operative time 105.2 ± 31.4 92.0 ± 33.5 0.002 Vaginal cuff suturing time 22.5 ± 3.8 11.4 ± 4.2 <0.001 Degree of surgical difficulty 6.8 ± 2.3 3.8 ± 2.0 <0.001 Estimated blood loss (mL) 80 (10-400) 50 (10-380) 0.054 Hemoglobin drop (mg/dL) 1.4 ± 1.0 1.4 ± 0.8 0.707 Failure of intended single-port TLH 8 (13.6%) 2 (4.6%) 0.185 Conversion to multi-port TLH 6 (10.2%) 1 (2.3%) Conversion to laparotomy 2 (3.4%) 0 Conversion to single-port LAVH 0 1 (2.3%) Operative complications Intraoperative complications 0 0 Postoperative complications 3 (5.1%) 1 (2.3%) 0.636 Vault bleeding 2 (3.3%) 1 (2.3%) >0.999 Transfusion 1 (1.7%) 0 >0.999 Postoperative pain score (VAS) at 12-hour after surgery 3.19 ± 0.71 3.12 ± 0.82 0.845 at 24-hour after surgery 2.62 ± 0.92 2.61 ± 0.88 0.782 at 48-hour after surgery 2.02 ± 0.89 2.13 ± 0.61 0.353 Length of hospital stay (days) 3 (2-5) 3 (2-4) 0.827 Data are expressed as the mean ± standard deviation, median (range) or frequency (proportion), as appropriate. TLH, total laparoscopic hysterectomy; LAVH, laparoscopically assisted vaginal hysterectomy; VAS, visual analog scale.

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http://www.AAGL.org/jmig-21-4-JMIG-D-13-00696

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http://www.AAGL.org/jmig-21-4-JMIG-D-13-00696