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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patient and the epidemiology nurse will not know the treatgment assigned.

Study Groups

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Vitamin E acetate

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

Group Type EXPERIMENTAL

Vitamine E Acetate

Intervention Type DRUG

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

Control group

No ointment will be applied

Group Type SHAM_COMPARATOR

No application of vitamin E acetate

Intervention Type DRUG

Vitamin E acetate ointment will not be applied in this group

Interventions

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Vitamine E Acetate

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

Intervention Type DRUG

No application of vitamin E acetate

Vitamin E acetate ointment will not be applied in this group

Intervention Type DRUG

Other Intervention Names

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Vitamin E acetate ointment No application of vitamin E acetate oinment

Eligibility Criteria

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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