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

University of Verona

Status: Not yet enrolling

Conditions: Vaginal Cuff Complications

Treatments: Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture; Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture

Study type: Interventional

Funder types: Other

Identifiers

NCT05833204

BARD

Details and patient eligibility

About

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.

Enrollment: 1,614 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,614 participants in 2 patient groups

Colporrhaphy with barbed absorbable suture

Experimental group

Description:

The colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)

Treatment:

Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture

Colporrhaphy with standard absorbable suture

Active Comparator group

Description:

The colporrhaphy will be performed using a standard 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ)

Treatment:

Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture