search
Back to results

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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Vitamine E Acetate
No application of vitamin E acetate
Sponsored by
Hospital General Universitario Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • General Hospital Elche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Vitamin E acetate

Control group

Arm Description

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

No ointment will be applied

Outcomes

Primary Outcome Measures

Postoperative pain
Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)

Secondary Outcome Measures

Full Information

First Posted
December 4, 2018
Last Updated
February 13, 2020
Sponsor
Hospital General Universitario Elche
search

1. Study Identification

Unique Protocol Identification Number
NCT03765827
Brief Title
Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass
Official Title
Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario Elche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and the epidemiology nurse will not know the treatgment assigned.
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin E acetate
Arm Type
Experimental
Arm Description
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No ointment will be applied
Intervention Type
Drug
Intervention Name(s)
Vitamine E Acetate
Other Intervention Name(s)
Vitamin E acetate ointment
Intervention Description
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
Intervention Type
Drug
Intervention Name(s)
No application of vitamin E acetate
Other Intervention Name(s)
No application of vitamin E acetate oinment
Intervention Description
Vitamin E acetate ointment will not be applied in this group
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damian Garcia, MD, PhD
Organizational Affiliation
Hospital Rey Juan Carlos
Official's Role
Study Director
Facility Information:
Facility Name
General Hospital Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32342266
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs