Status:
WITHDRAWN
Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass
Lead Sponsor:
Spital Limmattal Schlieren
Conditions:
Bariatric Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery. Since marginal ulceration is a known complication after this Operation, a Proton pump ...
Detailed Description
This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant (dexlansoprazole)....
Eligibility Criteria
Inclusion
- Informed consent for study and surgery as documented by signature
- Male and Female Patients over 18 years old eligible for bariatric surgery at the Department of General Surgery, Limmattal Hospital, according to criteria of the Swiss Study Group for Morbid Obesity (SMOB) and international Guidelines
- BMI ≥ 35
- Failure of conservative Treatment for 2 years
- Type of surgery: LPRYGB
- Helicobacter pylori negative
- Smoker (≥ 1 cigarette daily)
- Women in reproductive Age: negative pregnancy test
Exclusion
- Contraindication for a bariatric surgery according to SMOB-criteria
- Contraindication for PPIs
- Pregnant or breastfeeding women
- Pre- or intraoperative decision for other type of surgery than LPRYGB
- Active malignancy
- Chronic liver disease Child-Pugh B or C
- Abuse of drugs or alcohol
- Suspect of non-compliance
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04423588
Start Date
January 1 2022
End Date
September 30 2022
Last Update
December 2 2024
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