Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

Total Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02293369
• Other study ID #: 1424
• Status: Completed
• Phase: N/A
• First received: November 13, 2014
• Last updated: January 7, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Conditions
• Total Laparoscopic Hysterectomy

Intervention

Procedure:
• Cuff closure via vaginal route
Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
• Cuff closure via laparoscopic route
Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.

Locations

Country	Name	City	State
Turkey	Department of Obstetrics and Gynecology, Istanbul University School of Medicine	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University	University of Surrey

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Vaginal length	Vaginal measure will be taken prior to surgery and at 1-month follow-up.	One months	No
Secondary	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	No
Secondary	Vaginal cuff closure time	Cuff closure time will be recorded for each patient during the surgery.	One day	No