Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs. Laparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length. Various studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.

Official Title
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Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy and Their Effect on Female Sexual Function and Vaginal Length

Conditions
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Total Laparoscopic Hysterectomy, Benign Conditions

Intervention / Treatment
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* Procedure: Cuff closure via vaginal route
* Procedure: Cuff closure via laparoscopic route


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only Exclusion Criteria: Suspicion of malignancy Presence of large adnexal masses (maximum diameter >10 cm at preoperative ultrasonography)
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cuff closure via vaginal route<br>For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite and will continue toward the surgeon until the other uterosacral ligament will be incorporated into the repair, using a continuous 0-Vicryl suture in the vaginal route. | Procedure: Cuff closure via vaginal route<br>* Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.<br>|
| Active Comparator: Cuff closure via laparoscopic route<br>For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. In the laparoscopic approach, needles will be introduced through the umbilical trocar and removed through the peripheral trocars and intracorporeal knots will be utilized. | Procedure: Cuff closure via laparoscopic route<br>* Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function | Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up. | Three months | 
| Vaginal length | Vaginal measure will be taken prior to surgery and at 1-month follow-up. | One months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal cuff granulation/infection | Vaginal cuff granulation and any evidence of vaginal cuff infection will be carefully examined and documented during the 4-week follow-up visit | One month | 
| Vaginal cuff closure time | Cuff closure time will be recorded for each patient during the surgery. | One day |