Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure
- Conditions
- Gynecologic Surgical Procedures
- Registration Number
- NCT03038945
- Lead Sponsor
- CES University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cuff closure time 20 minutes time spend for vaginal Cuff closure (in minutes)
- Secondary Outcome Measures
Name Time Method Intra or postoperative complications 10 days Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam.
Dyspareunia 12 weeks the visual scale was used to analyze the dyspareunia
Trial Locations
- Locations (1)
Claudia Lopez
🇨🇴Medellin, Antioquia, Colombia
Claudia Lopez🇨🇴Medellin, Antioquia, Colombia