The primary objective of this study is to determine the progression over time of concentrations of faecal inflammatory markers before and after RYGB. Secondary objectives- To determine if patients with a sleeve gastrectomy have lower concentrations…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the concentration and progression over time of the faecal
inflammatory markers calprotectin, lactoferrin and calgranulin C, before and
until 1 year after RYGB.
Secondary outcome
Secondary outcomes
- Secondary outcome is the difference between concentrations of calprotectin,
lactoferrin and calgranulin-C after RYGB or sleeve gastrectomy
- Another outcome is the correlation between GSRS scores and concentration of
faecal inflammatory markers after bariatric surgery
Background summary
Roux-en-Y gastric bypass (RYGB) alters the gastrointestinal anatomy. This
influences food absorption, gut function and microbiome, also gastrointestinal
histological changes have been seen (1, 2). It may influence faeces
composition.
A recent study showed elevated concentrations of calprotectin, an inflammatory
marker, in the faeces of 87% of patients after RYGB (4). This may indicate the
occurrence of persisting (low-grade) gastrointestinal inflammation in the
majority of patients after RYGB.
Calprotectin is a protein mainly found in granulocytes, though also seen in
monocytes and epithelial cells. Faeces calprotectin testing is used in the
diagnosis and follow-up of inflammatory bowel diseases (IBD). This test must be
interpreted with caution after RYGB to prevent unnecessary invasive
endoscopies.
Other faecal inflammatory markers are lactoferrin and calgranulin-C (S100A12).
The latter being more specific for neutrophil granulocytes. Concentrations in
the faeces may be an indicator for infiltration of neutrophil granulocytes in
the gastrointestinal mucosa and gut inflammation.
Etiology and clinical relevance of the elevated faecal calprotectin after RYGB
is unknown. Also progression over time and place of issue of calprotectin has
yet to be investigated. If after bariatric surgery gastrointestinal
inflammation occurs, clinical relevance needs to be determined.
Some patients experience gastrointestinal complaints after RYGB, frequently
incompletely elucidated. It is unknown if these complaints are linked to the
concentration of inflammatory markers in the faeces. A frequently used method
to determine the degree of gastrointestinal complaints is by the
Gastrointestinal Symptom Rating Scale questionnaire. Persisting low-grade
gastrointestinal inflammation may partly explain these complaints.
Study objective
The primary objective of this study is to determine the progression over time
of concentrations of faecal inflammatory markers before and after RYGB.
Secondary objectives
- To determine if patients with a sleeve gastrectomy have lower concentrations
of faecal inflammatory markers than patients with a RYGB.
- To determine the correlation between gastrointestinal complaints and
concentration of markers of inflammation in the faeces after bariatric surgery.
Study design
Prospective longitudinal cohort study.
Once before and 6 weeks, 6 months and 1 year after RYGB or sleeve gastrectomy a
faeces sample is obtained from patients and analysed for concentrations of
calprotectin, lactoferrin and calgranulin-C. At the same moments, patients
will fill in the GSRS to determine gastrointestinal complaints.
Study burden and risks
The burden and risk for the participating patients are low. Patients have to
collect a faeces sample and fill in a questionnaire once before and three times
after surgery and bring this to the hospital during regular follow-up. No extra
hospital visits of investigations are needed.
Louwesweg 6
Amsterdam 1066 EC
NL
Louwesweg 6
Amsterdam 1066 EC
NL
Listed location countries
Age
Inclusion criteria
Patients who will undergo either a RYGB or sleeve gastrectomy.
Exclusion criteria
- Diarrhea at the time of faeces collection
- Useage of NSAID and unable tot stop for at least 5 days prior to faeces collection.
- Unable to fill out questionares because of linguistic difficulties
- An acute gastrointestinal disease at the time of participation or chronic gastrointestinal disease in the medical history
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 |
---|---|
Other | NTR 4761 |
CCMO | NL55820.048.15 |