NCT05833204: BARD

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

Not yet recruiting NA Last updated 28 June 2024

What this trial tests

NA trial testing Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture in Vaginal Cuff Complications in 1,614 participants. Not yet recruiting.

Timeline

1 March 2025

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Universita di Verona
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,614
Start date	1 March 2025
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across Italy

Drugs / interventions tested

• Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture
• Laparoscopic colporrhaphy with standard 0-caliber absorbable suture

Conditions studied

• Vaginal Cuff Complications — all drugs for Vaginal Cuff Complications →

Sponsor

Universita di Verona — full company profile →

Who can join

18 and older, female only, with Vaginal Cuff Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.