NCT03038945
Completed
Not Applicable
Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
CES University1 site in 1 country150 target enrollmentStarted: October 2016Last updated:
ConditionsGynecologic Surgical Procedures
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CES University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Cuff closure time
Overview
Brief Summary
Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of the problems described for this procedure has to do with the closure of the vaginal vault, increased surgical time when suture laparoscopically, complications such as dehiscence of the dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare two different techniques for closure of the vaginal vault.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients scheduled for total laparoscopic hysterectomy without other simultaneous procedures , for benign causes , who were agree to participate in the trial and give their written consent.
- •Patients ASA (American Society of Anesthesiologists) 1 and 2
- •Patients who are able to communicate by telephone and answer questions
Exclusion Criteria
- •Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic obstructive pulmonary disease), collagen diseases, diabetes.
- •Endometriosis III / IV
- •Patients who can not be reached by phone
Outcomes
Primary Outcomes
Cuff closure time
Time Frame: 20 minutes
time spend for vaginal Cuff closure (in minutes)
Secondary Outcomes
- Intra or postoperative complications(10 days)
- Dyspareunia(12 weeks)
Investigators
Claudia López
Gynecologist
CES University
Study Sites (1)
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