No registrations found.
ID
Source
Health condition
Roux-en-Y Gastric Bypass, morbid obesity, faecal, calprotectin, elastase, alpha-1-antitrypsin.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Determination of reference values of faecal calprotectin, elastase-1 and alpha-1-antitrypsin after RYGB
Background summary
The aim of this study is to determine reference values of faecal calprotectin, elastase-1 and alpha-1-antitrypsin after Roux-en-Y Gastric Bypass procedure (RYGB).
The prevalence of morbid obesity, and its associated comorbidities, is increasing worldwide. Bariatric surgery is the most effective long-term solution of morbid obesity, RYGB being one of the most performed procedures with a presumed restrictive and malabsorptive effect.
RYGB changes the anatomy of the gastro-intestinal tract. It affects the digestion and absorption of food in the bowel, which makes it likely to also affect the composition of faeces. In clinical practise, faecal measurements are used to diagnose, rule out or monitor the course of diseases.
Calprotectin is widely used as a diagnostic and prognostic marker of inflammatory bowel diseases. Faecal elastase-1 can be determined to diagnose and monitor patients with exocrine pancreatic insufficiency. Faecal alpha-1-antitrypsin is used to diagnose a protein-losing enteropathy.
A recent study showed significant changes in the faecal calprotectin and elastase-1 concentration in 7 patients after RYGB, compared to obese controls. To determine faecal reference values after RYGB keeps non-invasive faecal diagnostic tests in use for these patients and may contribute to better understanding of gut function and adaptation after RYGB.
Study objective
Because of modified anatomy of the gastro-intestinal tract after RYGB, which affects digestion and absorption of food, it is hypothesized that faecal composition after RYGB is also changed.
Study design
Between 12 and 24 months post-operative.
Intervention
N/A
T.C.C. Boerlage
Slotervaart Ziekenhuis
Louwesweg 6
1066 EC
Amsterdam
The Netherlands
+31 (0)20 5124945
thomas.boerlage@slz.nl
T.C.C. Boerlage
Slotervaart Ziekenhuis
Louwesweg 6
1066 EC
Amsterdam
The Netherlands
+31 (0)20 5124945
thomas.boerlage@slz.nl
Inclusion criteria
-Patients who are 12-24 months post-RYGB.
Exclusion criteria
- Patients who have diarrhoea at the time of faeces collection
- Patients who use a PPI or NSAID, without the possibility to discontinue this medication for at least 3 days
- Patients with an acute or chronic disease of stomach, intestine or pancreas which may influence the measurements made in this study.
E.g.: inflammatory bowel disease, malignancy of stomach, intestine or pancreas, chronic pancreatitis, chronic bowel infection, resection of stomach or bowel other than RYGB, radiotherapy with the gut laying within the ablated area, systemic disease which influences the gastro-intestinal tract (e.g. systemic sclerosis)
Not excluded are patients with e.g. cholecystectomy, bacterial gastro-enteritis or acute pancreatitis, provided that patients are fully recovered.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4610 |
| NTR-old | NTR4761 |
| Other | METC Slotervaartziekenhuis : P1437 |