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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Vitamine E Acetate; Drug: No application of vitamin E acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT03765827

HRJC 18-11

Details and patient eligibility

About

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 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).

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups

Vitamin E acetate

Experimental group

Description:

Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass

Treatment:

Drug: Vitamine E Acetate

Control group

Sham Comparator group

Description:

No ointment will be applied

Treatment:

Drug: No application of vitamin E acetate