|- candidate number||19355|
|- NTR Number||NTR4761|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||27-aug-2014|
|- Secondary IDs||P1437 METC Slotervaartziekenhuis|
|- Public Title||Faecal reference values after Roux-en-Y gastric bypass|
|- Scientific Title||Faecal reference values after Roux-en-Y gastric bypass|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Bariatric surgery, Overweight, Morbid obesity , Roux-en-Y gastric bypass surgery (RYGB)|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-mrt-2015|
|- Target number of participants||120|
|- Primary outcome||Determination of reference values of faecal calprotectin, elastase-1 and alpha-1-antitrypsin after RYGB|
|- Secondary outcome|
|- Timepoints||Between 12 and 24 months post-operative.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| T.C.C. Boerlage|
|- CONTACT for SCIENTIFIC QUERIES|| T.C.C. Boerlage|
|- Sponsor/Initiator ||Slotervaart Hospital|
(Source(s) of Monetary or Material Support)
|- Brief 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.
|- Main changes (audit trail)|
|- RECORD||27-aug-2014 - 22-sep-2014|