Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy

The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.

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Key information

Conditions

Surgical Wound Dehiscence Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All total laparoscopic hysterectomies performed by a single surgeon
Both benign and malignant cases
Completed laparoscopically
Intracorporeal vaginal cuff suturing

Exclusion criteria

Robotic hysterectomies
Pelvic infection within 30 days before surgery
Conversion to laparotomy

Treatment and study plan

Monopolar needle electrode

Device

Colpotomy during total laparoscopic hysterectomy

Primary outcomes

Vaginal dehiscence

Time frame: 3 months

Vaginal dehiscence up to 3 months after surgery

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Aug 25, 2016
Registry last updated: Sep 21, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed