Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass
Phase 3
Completed
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT03765827
- Lead Sponsor
- Hospital General Universitario Elche
- Brief Summary
Patients will be randomized into 2 groups:
* Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses
* Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery.
- Detailed Description
Patients will be randomized into 2 groups:
* Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.
* Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
- BMI >40 Kg/m2 or >35 Kg/m2 associated to obesity-related comorbidities
- Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
- Patients accepting to participate in the study and signing and Informed Consent form
Exclusion Criteria
- Patients undergoing other bariatric techniques
- Patients undergoing Roux-en-Y gastric bypass as revisional procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin E acetate Vitamine E Acetate Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass Control group No application of vitamin E acetate No ointment will be applied
- Primary Outcome Measures
Name Time Method Postoperative pain 24 hours after surgery Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
General Hospital Elche
🇪🇸Elche, Alicante, Spain