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

NCT05833204 | Not Yet Recruiting DMC

• 1 other identifier: BARD
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Cuff Complications

Keywords

Laparoscopy; Hysterectomy; Vaginal cuff closure; Barbed sutures; Vaginal cuff complications; Vaginal cuff dehiscence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Vaginal cuff complications

  30 days after surgery

• Vaginal cuff complications

  90 days after surgery

• Hospital stay

  From the date of hospital admission to the date of hospital discharge.

• Operative time

  During surgery

• Intraoperative blood loss

  During surgery

Study Arms (2)

Colporrhaphy with barbed absorbable suture

EXPERIMENTAL

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

Colporrhaphy with standard absorbable suture

ACTIVE COMPARATOR

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

Interventions

Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture PROCEDURE

After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)

Colporrhaphy with barbed absorbable suture

Laparoscopic colporrhaphy with standard 0-caliber absorbable suture PROCEDURE

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)

Colporrhaphy with standard absorbable suture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Verona, 37125, Italy

Location

Related Publications (2)

• Uccella S, Zorzato PC, Kho RM. Incidence and Prevention of Vaginal Cuff Dehiscence after Laparoscopic and Robotic Hysterectomy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2021 Mar;28(3):710-720. doi: 10.1016/j.jmig.2020.12.016. Epub 2021 Jan 5.

  PMID: 33348012 BACKGROUND

• Uccella S, Malzoni M, Cromi A, Seracchioli R, Ciravolo G, Fanfani F, Shakir F, Gueli Alletti S, Legge F, Berretta R, Corrado G, Casarella L, Donarini P, Zanello M, Perrone E, Gisone B, Vizza E, Scambia G, Ghezzi F. Laparoscopic vs transvaginal cuff closure after total laparoscopic hysterectomy: a randomized trial by the Italian Society of Gynecologic Endoscopy. Am J Obstet Gynecol. 2018 May;218(5):500.e1-500.e13. doi: 10.1016/j.ajog.2018.01.029. Epub 2018 Feb 2.

  PMID: 29410107 BACKGROUND

Study Officials

• Stefano Uccella, MD, PhD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Simone Garzon, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

• Pier Carlo Zorzato, MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Uccella, MD, PhD

CONTACT

0039 045 812 2720; stefano.uccella@univr.it

Simone Garzon, MD

CONTACT

0039 045 812 2720; simone.garzon@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The surgeon will not be blinded. Conversely, patients and co-investigators who will assess study outcomes and perform patients' follow-ups will be masked regarding the allocation arm until the study's conclusion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Multicenter, parallel arms, open-label, randomized controlled trial.

Study Record Dates

• First Submitted: April 1, 2023
• First Posted: April 27, 2023
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)