Roux-en-Y gastric bypass surgery (RYGB)
Conditions
Interventions
The subjects will be asked to take omeprazole 20 mg for a total duration of 2 weeks (day 1 – 14) before the RYGB surgery. After surgery, administration of omeprazole 20 mg twice daily is standard care
Sponsors
Department of Hospital Pharmacy
Medical Centre Haaglanden
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged between 18 and 65 years at the time of informed consent; 2. Written informed consent; 3. Scheduled to undergo RYGB surgery and approved to undergo this procedure according to the inclusion criteria of NOK West (Dutch Obesity Clinic West); 4. Ability to swallow whole medication tablets.
Exclusion criteria
Exclusion criteria: 1. Ulceration or leakage of the anastomosis post-surgery, to be determined 6 weeks after the RYGB surgery by the surgeon. This is an exclusion criterium for the second testday, to be determined during the study) - ‘Redo’ patients: patients previously treated for morbid obesity with a gastric sleeve or gastric banding; 2. Contra-indication to use ASA or omeprazole, e.g. known or suspected allergy; 3. Present use or use of drugs within 4 times the half-life of that drug before the start of the study that might interfere with the metabolism of the investigational drugs (inducers/inhibitors of CYP2C19); 4. Concurrent disease or increased risk of bleeding which may compromise safety of the administration of the study medication (e.g. Von Willebrands disease) according to the judgement of the investigator; 5. Gastro-intestinal disorders which may impair drug absorption (e.g. Crohn's disease or previous stomach or bowel surgery) according to the judgement of the investigator; 6. Treatment with any unlicensed drug during the previous month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameters are drug blood concentrations on the selected test days and times: 0 (before intake of the drugs), 30 minutes after intake, 1 hour, 2 hours and 4 hours after intake. With these concentrations the following pharmacokinetic parameters will be determined: Time to peak concentration (Tmax), peak concentration (Cmax), area under the curve (AUC), and half-life (t ½) of salicylic acid and omeprazole. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary study parameters are defined. | — |
Contacts
Public ContactLieke Winkelmolen
Apotheek Haagse Ziekenhuizen Postbus 43100
Outcome results
None listed