AOUI Verona - University of Verona - Department of Obstetrics and Gynecology
Verona, 37125, Italy
NCT Number: NCT05833204
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.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Verona, 37125, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)
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)
Time frame: 30 days after surgery
Any partial or total separation of the vaginal cuff
Time frame: 90 days after surgery
Any partial or total separation of the vaginal cuff
Time frame: 30 days after surgery
Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff
Time frame: 90 days after surgery
Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff
Time frame: From the date of hospital admission to the date of hospital discharge.
Days of hospitalization from the day of admission to the day of discharge.
Time frame: During surgery
Time between first incision and skin closure
Time frame: During surgery
Total blood aspirate during the surgical procedure
Time frame: 30 days after surgery
Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification
Time frame: 90 days after surgery
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.
Time frame: 90 days after surgery
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.
Contact information is provided by the study sponsor or research team.
Simone Garzon, MD
CONTACT
Stefano Uccella, MD, PhD
CONTACT
Universita di Verona
Other
Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
Acronym: BARD
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