Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Benign Conditions; Total Laparoscopic Hysterectomy

• Registration Number: NCT02293369
• Lead Sponsor: Istanbul University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Istanbul University School of Medicine; 🇹🇷 Istanbul, Turkey