Bariatric Surgery
Conditions
Keywords
Proton Pump Inhibitor
Brief 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.
Detailed 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 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.
Interventions
DIAGNOSTIC_TESTdexlansoprazole 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_TESTupper 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
Spital Limmattal Schlieren
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of dexlansoprazole Serum concentration | 3 months | Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 3 months after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Marginal ulceration | 6 months | Study of the incidence of marginal ulcers in the participants 6 months after surgery |
Contacts
PRINCIPAL_INVESTIGATORUrs Zingg, Prof. Dr. med.
Chefarzt Chirurgie, Limmattal Hospital
Outcome results
None listed