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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vaginal Cuff Complications
• Intervention / Treatment: Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture; Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture

• Study Type: Interventional
• Enrollment (Estimated): 1614
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Uccella, MD, PhD; Phone Number: 0039 045 812 2720; Email: stefano.uccella@univr.it
• Study Contact Backup: Name: Simone Garzon, MD; Phone Number: 0039 045 812 2720; Email: simone.garzon@univr.it

Study Locations

• Italy
  • Verona, Italy, 37125
    • AOUI Verona - University of Verona - Department of Obstetrics and Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colporrhaphy with barbed absorbable suture; 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; After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)
Active Comparator: Colporrhaphy with standard absorbable suture; 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; 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)

What is the study measuring?

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
30-day post-surgical morbidity	Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification	30 days after surgery
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
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

Collaborators and Investigators

• Sponsor: Universita di Verona
• Investigators: Principal Investigator: Stefano Uccella, MD, PhD, Universita di Verona; Principal Investigator: Simone Garzon, MD, Universita di Verona; Principal Investigator: Pier Carlo Zorzato, MD, Universita di Verona

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 1, 2023
• First Submitted That Met QC Criteria: April 15, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Laparoscopy; Hysterectomy; Barbed sutures; Vaginal cuff dehiscence; Vaginal cuff closure; Vaginal cuff complications
• Other Study ID Numbers: BARD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No