Status:
UNKNOWN
External Validation of a Microscopic Colitis Clinical Scoring System in Patients With Chronic Watery Diarrhoea
Lead Sponsor:
Hospital Mutua de Terrassa
Conditions:
Microscopic Colitis
Eligibility:
All Genders
40+ years
Brief Summary
Chronic watery diarrhoea is a very common problem in the population and most of these patients will be referred for colonoscopy. If no macroscopic findings are observed during colonoscopy to justify t...
Detailed Description
Two diagnostic scoring systems have been proposed to predict the risk of developing MC: 1) The Kane score (sensitivity (SN) 96%; specificity (SP) 46%) combines eight risk factors, including female sex...
Eligibility Criteria
Inclusion
- Age 40 years or older.
- Patient with chronic non-bloody watery diarrhoea (Bristol scale=6 or 7), with 2 or more liquid stools per day, of frequent occurrence (at least 3 times per week), of at least 1 month's duration.
- Normal blood test and biochemistry (including C reactive protein and TSH), negative anti-transglutaminase antibodies, and negative faecal ova and parasites. A 75SeHCAT is not mandatory.
- Patients with an indication for a diagnostic colonoscopy by their physician at charge, mainly to rule out MC.
- Signature of the study informed consent
Exclusion
- Patients with either alternating diarrhoea-constipation or self-limiting diarrhoea at the time of colonoscopy.
- History of inflammatory bowel disease or coeliac disease, bile acid diarrhoea.
- Previous gastrointestinal surgery (excluding appendectomy or inguinal herniorrhaphy).
- Incomplete colonoscopy or no colon biopsies of at least right and left colon in separate containers (minimum 2 samples of each segment).
- Unsatisfactory preparation for a complete exploration (Boston scale \<6, any segment \<2)
- Significant macroscopic lesions on colonoscopy, other than those occasionally described in MC
- Inability to understand the instructions for participating in the study.
Key Trial Info
Start Date :
May 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06031064
Start Date
May 15 2022
End Date
February 1 2024
Last Update
September 11 2023
Active Locations (1)
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1
Hospital Universitari MútuaTerrassa
Terrassa, Barcelona, Spain, 08221