Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass

Overview

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.

Full Title of Study: “Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2019

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).

Interventions

  • Drug: Vitamine E Acetate
    • Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
  • Drug: No application of vitamin E acetate
    • Vitamin E acetate ointment will not be applied in this group

Arms, Groups and Cohorts

  • Experimental: Vitamin E acetate
    • Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
  • Sham Comparator: Control group
    • No ointment will be applied

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pain
    • Time Frame: 24 hours after surgery
    • Postoperative pain will be assessed by means of a Visual Analogic Scale (0-100mm)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital General Universitario Elche
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery – Hospital General Universitario Elche
  • Overall Official(s)
    • Damian Garcia, MD, PhD, Study Director, Hospital Rey Juan Carlos
  • Overall Contact(s)
    • Jaime Ruiz-Tovar, MD, PhD, (0034)630534808, jruiztovar@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.