Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Total Laparoscopic Hysterectomy; Benign Conditions
• Intervention / Treatment: Procedure: Cuff closure via vaginal route; Procedure: Cuff closure via laparoscopic route

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Department of Obstetrics and Gynecology, Istanbul University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cuff closure via vaginal route; 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; Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
Active Comparator: Cuff closure via laparoscopic route; 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; Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: University of Surrey
• Investigators: Study Chair: Faruk Buyru, M.D., Istanbul University School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 13, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1424