Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass
Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 postoperative-pain
Started Dec 2018
Shorter than P25 for phase_3 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2018
CompletedFirst Posted
Study publicly available on registry
December 5, 2018
CompletedStudy Start
First participant enrolled
December 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedFebruary 17, 2020
February 1, 2020
5 months
December 4, 2018
February 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Vitamin E acetate
EXPERIMENTALVitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Control group
SHAM COMPARATORNo ointment will be applied
Interventions
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Vitamin E acetate ointment will not be applied in this group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients undergoing other bariatric techniques
- Patients undergoing Roux-en-Y gastric bypass as revisional procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital Elche
Elche, Alicante, 03203, Spain
Related Publications (1)
Ruiz-Tovar J, Garcia A, Ferrigni C, Duran M. Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants. Obes Surg. 2020 Aug;30(8):2988-2993. doi: 10.1007/s11695-020-04635-9.
PMID: 32342266DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Damian Garcia, MD, PhD
Hospital Rey Juan Carlos
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The patient and the epidemiology nurse will not know the treatgment assigned.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Surgery
Study Record Dates
First Submitted
December 4, 2018
First Posted
December 5, 2018
Study Start
December 5, 2018
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02