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

NCT ID: NCT05833204

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1614 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Colporrhaphy with barbed absorbable suture

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

Group Type: EXPERIMENTAL

Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture

Intervention Type: PROCEDURE

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

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)

Group Type: ACTIVE_COMPARATOR

Laparoscopic colporrhaphy with standard 0-caliber absorbable suture

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Stefano Uccella

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Uccella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Simone Garzon, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Pier Carlo Zorzato, MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

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

Verona, , Italy

Countries

Italy

Central Contacts

Stefano Uccella, MD, PhD

Role: CONTACT

stefano.uccella@univr.it

0039 045 812 2720

Simone Garzon, MD

Role: CONTACT

simone.garzon@univr.it

0039 045 812 2720

References

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.

Reference Type: BACKGROUND

PMID: 33348012 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29410107 (View on PubMed)

Other Identifiers

BARD

Identifier Type: -

Identifier Source: org_study_id