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Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

NCT ID: NCT04423588

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bariatric Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dexlansoprazole

The PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning.

Group Type OTHER

dexlansoprazole serum concentration

Intervention Type DIAGNOSTIC_TEST

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.

upper endoscopy

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spital Limmattal Schlieren

OTHER

Sponsor Role lead

Responsible Party

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Prof Urs Zingg

Prof. Dr. med. Urs Zingg

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Urs Zingg, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Chefarzt Chirurgie, Limmattal Hospital

Other Identifiers

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2019-02326

Identifier Type: -

Identifier Source: org_study_id