Clinical trial NCT05833204: BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy
Official title: Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaginal Cuff Complications
Keywords: Laparoscopy
Hysterectomy
Vaginal cuff closure
Barbed sutures
Vaginal cuff complications
Vaginal cuff dehiscence
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2023-04-27
Enrollment: 1614
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, parallel arms, open-label, randomized controlled trial.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Vaginal cuff dehiscence
timeFrame: 30 days after surgery
measure: Vaginal cuff dehiscence
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Vaginal cuff complications
timeFrame: 30 days after surgery
measure: Vaginal cuff complications
timeFrame: 90 days after surgery
measure: Hospital stay
timeFrame: From the date of hospital admission to the date of hospital discharge.
measure: Operative time
timeFrame: During surgery
measure: Intraoperative blood loss
timeFrame: During surgery
measure: 30-day post-surgical morbidity
timeFrame: 30 days after surgery
measure: Quality of life index
timeFrame: 90 days after surgery
measure: Sexual function
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Study officials:
affiliation: Universita di Verona
name: Stefano Uccella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Simone Garzon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita di Verona
name: Pier Carlo Zorzato, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.