WithdrawnPhase 4

Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass

Stopped: No participants enrolled.

0Started 2022-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of dexlansoprazole Serum concentration

Timeframe: 3 months

Change of dexlansoprazole Serum concentration

Timeframe: 6 months

Trial details

NCT IDNCT04423588

SponsorSpital Limmattal Schlieren

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-31

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