BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications. Among other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators. Therefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.

Official Title
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Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial

Conditions
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Vaginal Cuff Complications

Intervention / Treatment
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* Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture
* Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective total laparoscopic hysterectomy Surgery performed for the treatment of benign pathology Age > 18 years Surgery performed by laparoscopy Signature of informed consent Exclusion Criteria: Patients undergoing emergent surgery Patients candidates for hysterectomy for oncological indication Patients who underwent previous radiation therapy Patients allergic to the suture material used in the study Patients unable to express adequate informed consent to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter, parallel arms, open-label, randomized controlled trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colporrhaphy with barbed absorbable suture<br>The colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic) | Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture<br>* After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)<br>|
| Active Comparator: Colporrhaphy with standard absorbable suture<br>The colporrhaphy will be performed using a standard 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ) | Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture<br>* After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal cuff dehiscence | Any partial or total separation of the vaginal cuff | 30 days after surgery | 
| Vaginal cuff dehiscence | Any partial or total separation of the vaginal cuff | 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal cuff complications | Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff | 30 days after surgery | 
| Vaginal cuff complications | Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff | 90 days after surgery | 
| Hospital stay | Days of hospitalization from the day of admission to the day of discharge. | From the date of hospital admission to the date of hospital discharge. | 
| Operative time | Time between first incision and skin closure | During surgery | 
| Intraoperative blood loss | Total blood aspirate during the surgical procedure | During surgery | 
| 30-day post-surgical morbidity | Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification | 30 days after surgery | 
| Quality of life index | The Short Form 12 Health Survey (SF-12) investigates 8 different health aspects. Physical activity, role and physical health, role and emotional state, and mental health are measured by two questions. The SF-12 scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. | 90 days after surgery | 
| Sexual function | The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function. | 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Hysterectomy, Vaginal cuff closure, Barbed sutures, Vaginal cuff complications, Vaginal cuff dehiscence