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OpenTrials
Completed

NCT Number: NCT02293369

Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Istanbul University School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cuff closure via vaginal route

Procedure

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

Cuff closure via laparoscopic route

Procedure

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

Primary outcomes

  1. Female Sexual Function

    Time frame: Three months

    Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up.

  2. Vaginal length

    Time frame: One months

    Vaginal measure will be taken prior to surgery and at 1-month follow-up.

Secondary outcomes

  1. Vaginal cuff granulation/infection

    Time frame: 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

  2. Vaginal cuff closure time

    Time frame: One day

    Cuff closure time will be recorded for each patient during the surgery.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • University of Surrey

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 18, 2014
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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