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 range18 Years

SexALL

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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

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