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OpenTrials
Completed

NCT Number: NCT03765827

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

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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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

General Hospital Elche

Elche, Alicante, 03203, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamine E Acetate

Drug

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

Other names: Vitamin E acetate ointment

No application of vitamin E acetate

Drug

Vitamin E acetate ointment will not be applied in this group

Other names: No application of vitamin E acetate oinment

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 5, 2018
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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