Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

NCT02293369 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-01-08

No results posted yet for this study

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

Interventions

PROCEDURE

Cuff closure via vaginal route

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

PROCEDURE

Cuff closure via laparoscopic route

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

Sponsors & Collaborators

  • University of Surrey

    collaborator OTHER
  • Istanbul University

    lead OTHER

Principal Investigators

  • Faruk Buyru, M.D. · Istanbul University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-10-31
Completion
2015-11-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02293369 on ClinicalTrials.gov