MedTrace Logo

Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

NCT04423588 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-12-02

No results posted yet for this study

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 Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs. There are only very little data on the pharmacokinetics of PPIs following PRYGB.

The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population.

Conditions

  • Bariatric Surgery

Interventions

DIAGNOSTIC_TEST

dexlansoprazole serum concentration

6 blood samples are collected at fixed time Points after oral Administration of 1 dose of dexilant at regular patients visits preoperatively and 3 and 6 months post-surgery.

DIAGNOSTIC_TEST

upper endoscopy

6 and 12 months after surgery the occurrence of marginal ulcers in the same Patient Group is examined by upper endoscopy. The 12-month endoscopy is part of the Routine postoperative diagnosis, the 6-month endoscopy is for study purpose.

Sponsors & Collaborators

  • Spital Limmattal Schlieren

    lead OTHER

Principal Investigators

  • Urs Zingg, Prof. Dr. med. · Chefarzt Chirurgie, Limmattal Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-03-31
Completion
2022-09-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423588 on ClinicalTrials.gov