Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

NCT02293369 | Completed

• 1 other identifier: 1424
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Laparoscopic Hysterectomy; Benign Conditions

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Vaginal cuff granulation/infection

  One month

• Vaginal cuff closure time

  One day

Study Arms (2)

Cuff closure via vaginal route

ACTIVE COMPARATOR

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

Cuff closure via laparoscopic route

ACTIVE COMPARATOR

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

Interventions

Cuff closure via vaginal route PROCEDURE

Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.

Cuff closure via vaginal route

Cuff closure via laparoscopic route PROCEDURE

Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.

Cuff closure via laparoscopic route

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only

You may not qualify if:

• Suspicion of malignancy
• Presence of large adnexal masses (maximum diameter \>10 cm at preoperative ultrasonography)

Sponsors & Collaborators

• Istanbul University: lead
• University of Surrey: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Study Officials

• Faruk Buyru, M.D.

  Istanbul University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 18, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 8, 2016

Record last verified: 2016-01

Locations

TU (1)