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

Postoperative Pain Clinical Trial

Official title:

Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03765827
• Other study ID #: HRJC 18-11
• Status: Completed
• Phase: Phase 3
• Start date: December 5, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: February 2020
• Source: Hospital General Universitario Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Spain	General Hospital Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)	24 hours after surgery