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NCT02879487 Clinical Trial

Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy

Surgical Wound Dehiscence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02879487
Other study ID # 01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date September 2017

Study information
Verified date September 2020
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Monopolar needle electrode
Colpotomy during total laparoscopic hysterectomy

Locations
Country Name City State
Turkey Ankara University Medical Faculty Hospital Ankara

Sponsors (1)
Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vaginal dehiscence Vaginal dehiscence up to 3 months after surgery 3 months
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