Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
Overview
- Phase
- Phase 3
- Intervention
- Vitamine E Acetate
- Conditions
- Postoperative Pain
- Sponsor
- Hospital General Universitario Elche
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Postoperative pain
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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).
Investigators
Jaime Ruiz-Tovar, MD, PhD
Department of Surgery
Hospital General Universitario Elche
Eligibility Criteria
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
Arms & Interventions
Vitamin E acetate
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Intervention: Vitamine E Acetate
Control group
No ointment will be applied
Intervention: No application of vitamin E acetate
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 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)