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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03765827
Enrollment
140
Registered
2018-12-05
Start date
2018-12-05
Completion date
2019-04-30
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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).

Interventions

DRUGVitamine E Acetate

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

DRUGNo application of vitamin E acetate

Vitamin E acetate ointment will not be applied in this group

Sponsors

Hospital General Universitario Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain24 hours after surgeryPostoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026