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Trial record 7 of 453 for:    applied AND ointment

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

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ClinicalTrials.gov Identifier: NCT03765827
Recruitment Status : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Vitamine E Acetate Drug: No application of vitamin E acetate Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient and the epidemiology nurse will not know the treatgment assigned.
Primary Purpose: Prevention
Official Title: Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
Estimated Study Start Date : December 5, 2018
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019


Arm Intervention/treatment
Experimental: Vitamin E acetate
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Drug: Vitamine E Acetate
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Other Name: Vitamin E acetate ointment

Sham Comparator: Control group
No ointment will be applied
Drug: No application of vitamin E acetate
Vitamin E acetate ointment will not be applied in this group
Other Name: No application of vitamin E acetate oinment




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours after surgery ]
    Postoperative pain will be assessed by means of a Visual Analogic Scale (0-100mm)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765827


Contacts
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Contact: Jaime Ruiz-Tovar, MD, PhD (0034)630534808 jruiztovar@gmail.com
Contact: Manuel Duran, MD, PhD (0034)682357456 manuel.duran@hrjc.es

Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Study Director: Damian Garcia, MD, PhD Hospital Rey Juan Carlos

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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT03765827     History of Changes
Other Study ID Numbers: HRJC 18-11
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents