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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing

Conditions
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Surgical Wound Dehiscence

Intervention / Treatment
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* Procedure: TRANSVAGINAL SUTURE
* Procedure: LAPAROSCOPIC SUTURE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy Exclusion Criteria: Patients with gynecological malignancy (uterine and/or adnexal)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRANSVAGINAL SUTURE<br>INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders. | Procedure: TRANSVAGINAL SUTURE<br>* The closure of the vaginal cuff will be performed transvaginally using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with vaginal valves and needleholders<br>|
| Active Comparator: LAPAROSCOPIC SUTURE<br>INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders. | Procedure: LAPAROSCOPIC SUTURE<br>* The closure of the vaginal cuff will be performed laparoscopically using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with laparoscopic needleholders<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAGINAL DEHISCENCE | 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. | 3 months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAGINAL CUFF COMPLICATIONS | Vaginal bleeding Need for Vaginal re-suture Vaginal vault prolapse Dyspareunia Post-operative pelvic infection | 3 months postoperatively | 
| operative time | Time spent in suturing the vaginal cuff transvaginally vs. laparoscopically | During Operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal dehiscence