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

Vaginal Cuff Complications Clinical Trial

— BARD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05833204
• Other study ID #: BARD
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Universita di Verona
• Contact: Stefano Uccella, MD, PhD
• Phone: 0039 045 812 2720
• Email: stefano.uccella[@]univr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1614
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vaginal Cuff Complications

Intervention

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)
• 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)

Locations

Country	Name	City	State
Italy	AOUI Verona - University of Verona - Department of Obstetrics and Gynecology	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal cuff dehiscence	Any partial or total separation of the vaginal cuff	30 days after surgery
Primary	Vaginal cuff dehiscence	Any partial or total separation of the vaginal cuff	90 days after surgery
Secondary	Vaginal cuff complications	Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff	30 days after surgery
Secondary	Vaginal cuff complications	Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff	90 days after surgery
Secondary	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.
Secondary	Operative time	Time between first incision and skin closure	During surgery
Secondary	Intraoperative blood loss	Total blood aspirate during the surgical procedure	During surgery
Secondary	30-day post-surgical morbidity	Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification	30 days after surgery
Secondary	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
Secondary	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