DOI: 10.5061/dryad.0gb5mkm5t
title: Comparison of different suture techniques for laparoscopic vaginal cuff closure

description: Laparoscopic hysterectomy is a commonly performed procedure. However, one
 high-risk complication is vaginal cuff dehiscence. Currently, there is no
 standardization regarding thread material or suturing technique for
 vaginal cuff closure. Therefore, this study aimed to compare
 extracorporeal and intracorporeal suturing techniques for vaginal cuff
 closure using a pelvic trainer model. Eighteen experts in laparoscopic
 surgery performed vaginal cuff closures with interrupted sutures using
 intracorporeal knotting, extracorporeal knotting and continuous,
 unidirectional barbed sutures. While using an artificial tissue suturing
 pad in a pelvic trainer, experts performed vaginal cuff closure using each
 technique according to block randomization. Task completion time, tension
 resistance, and the number of errors were recorded. After completing the
 exercises, participants answered a questionnaire concerning the suturing
 techniques and their performance. Experts completed suturing more quickly
 (p &lt; 0.001, p &lt; 0.001, respectively) and with improved
 tension resistance (p &lt; 0.001, p &lt; 0.001) when using barbed
 suturing compared to intracorporeal and extracorporeal knotting.
 Furthermore, the intracorporeal knotting technique was performed faster (p
 = 0.04) and achieved greater tension resistance (p = 0.023) compared to
 extracorporeal knotting. The number of laparoscopic surgeries performed
 per year was positively correlated with vaginal cuff closure duration (p =
 0.007). Barbed suturing was a time-saving technique with improved tension
 resistance for vaginal cuff closure.
description: <strong>Study
 design</strong> We conducted a prospective,
 randomized controlled study at the University Hospital Basel from the
 1<sup>st </sup>November 2021 to
 30<sup>th</sup> April 2022. Eighteen participants were
 randomized in block randomizations of three. All participants performed
 interrupted intracorporeal, extracorporeal, and continuous barbed suturing
 for VCC using each technique according to their
 randomization.<strong> </strong>For the primary endpoint, the
 time required to complete a task was recorded during each participant’s
 performance. Following the task, the secondary endpoints (i) precision, (ii) knot strength, (iii)
 cuff closure spreadability, and (iv) number of mistakes made were
 measured. Before and after completing the tasks, participants
 were given questionnaires. The first
 asked about their background and the second about their experience while
 completing the exercises. (Figure 1).  <strong>Power
 analysis</strong> The required sample size was
 estimated using a power analysis, calculated based on two-sided, paired
 t-tests with power set to 90% and the significance level at 0.05. While a
 minimum of 18 subjects was indicated, the statistical distribution of the
 task duration time was unknown and, therefore, the calculation was a
 pragmatic approximation.  <strong>Study
 population</strong> In total, 18 experts were
 successfully recruited with a dropout rate of zero, and 54 measurements
 were obtained. Qualifying as an expert required one to be a surgeon with
 more than five years of operative experience and more than thirty
 laparoscopic interventions per year. Study participants were recruited from one
 tertiary and three secondary hospitals. All methods were carried out in
 accordance with the CONSORT statement guidelines. A formal IRB
 certification of exemption (Req-2021-01075) was provided by the ethics committee
 of Northwest and Central Switzerland (EKNZ) on September 22, 2021, which
 confirmed that the research project fulfilled the general ethical and
 scientific standards for research with human subjects. All participants
 gave their written, informed consent to participate in the study. The
 anonymization of personal data was guaranteed.
 <strong>Instrument
 set-up</strong> All exercises were
 carried out on a box trainer. An endoscopy tower was equipped with a
 24-inch monitor and a 300 W Xenon light source (Karl Storz SE &
 Co., Tuttlingen, Germany) and a Storz Hopkins II, 10 mm, 0° telescope with
 a Xenon Nova 300 light source and an Image 1 H3-Z Full HD camera (Karl
 Storz SE & Co., Tuttlingen, Germany) were used. Two
 access points equivalent to the lateral ancillary trocar entry points were
 used for the instruments. Two needle holders (Geyl Medical 801.023),
 laparoscopic scissors, and a closed jaw type knot pusher (Karl Storz 26596
 D closed jaw end) were used. <strong>Exercises</strong> The colpotomy model was made of mesh-augmented silicone with a similar shape and size as a real colpotomy and was set up on the posterior wall of the box trainer. A brief instructional video showed the three different suturing techniques. After a short individual warm-up (20 minutes maximum) the experts began the different suturing techniques according to their randomization, completing one run per suture type for three runs in total.  <strong>A. Vaginal cuff closure with intracorporeal interrupted suturing </strong> Suture A was a closure technique using three interrupted figure-eight sutures and intracorporeal knotting with a polyfilament thread (Vicryl, polyglactin 910, Johnson & Johnson). These three sutures were performed with a surgeon’s knot, which translated to securing the knot with three loops. (Video 1). <strong>B. Vaginal cuff closure with extracorporeal interrupted suturing</strong> Suture B used the same closure technique as suture A but with knotted extracorporeal polyfilament thread (Vicryl, polyglactin 910, Johnson & Johnson). The three interrupted figure-eight sutures were performed with a surgeon’s knot. The tightening of the knots was made with one hand and tightened with a knot pusher<strong> </strong>(Video 2). <strong>C. Vaginal cuff closure with barbed continuous suturing</strong> Suture C was a continuous, unidirectional barbed suture made with V-Loc™ (180 Absorbable Wound Closure Device; Covidien, Mansfield, MA, USA). This suture was made unidirectional. Thus, after the first stitch, the thread was pulled through the loop. After 5 more stitches from right to left, the thread was cut at the end of the colpotomy without extra anchoring stitches.<strong> </strong>(Video 3). <strong>Questionnaires</strong> Participants answered questionnaires before and after the exercises. The questionnaire given before the exercises concerned general participant characteristics including sex, age, whether and how often they played video games, what types of sports and instruments they played, and their background regarding surgical and technical skills. After completing the exercises, participants answered a questionnaire regarding how they felt, both mentally and physically, about their experience with the different suturing techniques.  <strong>Statistical analyses</strong> Descriptive statistics are presented as counts and frequencies for categorical data. For metric variables, means with standard deviations, medians, and interquartile ranges were used. Linear mixed-effects models were used to predict spreading capacity with technique and run as predictor variables. Results are presented as mean differences. For total run time and changes in knot strength, the variables were log-transformed, and the results presented as geometric mean ratios. A p-value &lt;0.05 was considered significant. The statistical software R (version 4.1.3) was used for the analyses.
description: # Data\_template\_experts\_vaginal\_cuff\_closure Study design We
 conducted a prospective randomized controlled study. Eighteen participants
 were randomized in block randomizations of three. All participants
 performed interrupted intracorporeal, extracorporeal, and continuous
 barbed suture for VCC. They performed a VCC of each technique according to
 their randomization. For the primary endpoint, the time required to
 complete a task was recorded during each participants performance. After
 the task, the secondary endpoints (i) precision, (ii) knot strength, (iii)
 cuff closure spread ability, and (iv) number of mistakes made were
 measured. Before and after completing the tasks, participants were given a
 questionnaire asking about their background and their experience while
 completing the exercises. Figure 1 Exercises The colpotomy model was made
 of mesh-augmented silicone with a similar shape and size as the real
 colpotomy, and was set up on the posterior wall of the box trainer. A
 short video instruction showed the three different suture techniques.
 After a short individual warm-up time for a maximum of 20 minutes, the
 experts started with the different suture techniques according to their
 randomization, completing one run per suture type three runs in total.
 There were five outcomes of interest: (a) task time, (b) number of
 mistakes, precision, (d) knot strength, and (e) cuff closure spread
 ability. To measure task completion time, areas were marked to define the
 start position for the laparoscopic instruments. The task started at this
 position and was finished once the remains of the thread had been
 completely removed. A mobile phone with a start/stop feature was used to
 record the time elapsed at the end of every run and was used to measure
 the time required for each task to be completed. Mistakes were manually
 counted and recorded. Precision was measured by the distance of the
 puncture to the marked puncture in millimetres with a digital calliper.
 Next, these 12 distances were cumulatively added per suture technique and
 the mean was calculated. Third, the spread-ability of the cuff closure was
 measured with a spring balance by attaching both sides and pulling them
 apart with 10 Newtons. The distance between the colpotomy borders was
 measured with a digital calliper. Next, they were compared to the
 colpotomy borders without any pulling force. This way, the closure could
 be checked for quality and revealed fully or insufficiently tightened
 knots. The knot strength for suture was measured by a spring balance as
 well. For A and B, if the knot was not tightened correctly by the surgeons
 knot with three loops, the knot could freely move, increasing the thread
 distance as a result. Therefore, one of the thread ends was fixed in a
 self-made device and the knot was held by a perforated plastic disk while
 the other end was pulled through the hole. The thread was measured after
 having been pulled with 0 N, 5 N, 10 N and 15 N and the added length gain
 was calculated compared to the baseline (0 N). Subsequently, suture C, the
 V-Loc loop, was examined. Since it is a thread without a knot, the
 measurement had to be adapted. The V-Loc thread was marked with a pen
 longitudinally in the middle along the cuff. The same weights (5 N, 10 N
 and 15 N) then pulled on the first, second and third stitch. After
 pulling, the length increased between the pen mark and the puncture site
 was measured and noted. # Description of the data and file structure
 \#legends data exercises ![](https://i.imgur.com/toCVUvE.png) \#legends
 data questionnaire ![](https://imgur.com/xUo0i6a.png)