Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Closure

Not Applicable

Completed

• Conditions: Surgical Wound Dehiscence
• Interventions: Procedure: LAPAROSCOPIC SUTURE; Procedure: TRANSVAGINAL SUTURE

• Registration Number: NCT02453165
• Lead Sponsor: Università degli Studi dell'Insubria

Brief Summary

Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.

The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.

Detailed Description

A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy.

The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault.

The investigators will also compare the two modalities in terms of:

* duration of the vaginal closure

* risk of bleeding from the vaginal cuff

* risk of post-operative pelvic infection

* risk of re-operation

* dyspareunia

* total vaginal length

* vaginal cuff prolapse.

Study Timeline

• Study Start: 2015-02-01
• Study First Submitted: 2015-02-03
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-25
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1408

Inclusion Criteria

• Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy

Exclusion Criteria

• Patients with gynecological malignancy (uterine and/or adnexal)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LAPAROSCOPIC SUTURE	LAPAROSCOPIC SUTURE	INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders.
TRANSVAGINAL SUTURE	TRANSVAGINAL SUTURE	INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders.

Primary Outcome Measures

Name	Time	Method
VAGINAL DEHISCENCE	3 months postoperatively	Vaginal dehiscence defined as any partial or complete separation of the vaginal vault, sutured at the end of a total laparoscopic hysterectomy.; This complication is diagnosed clinically, during a gynecologic visit. Every dehiscence (whether partial or total) will be considered as an outcome event and we will measure the presence/absence of dehiscence as a percentage of the total procedures.

Secondary Outcome Measures

Name	Time	Method
VAGINAL CUFF COMPLICATIONS	3 months postoperatively	* Vaginal bleeding; * Need for Vaginal re-suture; * Vaginal vault prolapse; * Dyspareunia; * Post-operative pelvic infection
operative time	During Operation	Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology Universita' Dell'Insubria; 🇮🇹 Varese, Italy