Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bariatric Surgery
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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). The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole. Peripheral ...
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). The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6 months after surgery. The incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is made by measuring serum drug concentration, patient questionnaires, pill count and upper endoscopy.
Tracking Information
- NCT #
- NCT04423588
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Urs Zingg, Prof. Dr. med. Chefarzt Chirurgie, Limmattal Hospital
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