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.
Patients undergoing elective total laparoscopic hysterectomy
Surgery performed for the treatment of benign pathology
Age > 18 years
Surgery performed by laparoscopy
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
Parallel
Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture
Procedure/SurgeryAfter 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
Procedure/SurgeryAfter 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)
Vaginal cuff dehiscence
Any partial or total separation of the vaginal cuff
Vaginal cuff dehiscence
Any partial or total separation of the vaginal cuff
Vaginal cuff complications
Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff
Vaginal cuff complications
Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff
Hospital stay
Days of hospitalization from the day of admission to the day of discharge.
Operative time
Time between first incision and skin closure
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