Determination of the Aetiologies of Acute Colitis and Early Identification of Patients Requiring Diagnostic Colonoscopy

NCT02709213 | Completed

• 1 other identifier: 14-211
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The aetiologies of computed tomography-diagnosed acute colitis remain surprisingly unknown. Moreover, no diagnostic tool or clinical score allow to quickly determine or at least stratify the exact cause of colitis in patients admitted at an Emergency Ward and to direct them to the appropriate therapeutic care. The aims of the present study are to describe the presentation and aetiologies of acute colitis, and to develop diagnostic methods to guide patients admitted for acute colitis to the appropriate therapeutic care, notably colonoscopy.

Conditions

Colitis

Keywords

Inflammatory chronic bowel disease; ICBD; Colorectal cancer; Infectious colitis

Outcome Measures

Primary Outcomes (1)

• Determination of the aetiologies of colitis using microbiological examination of the stools +/- colonoscopy

  Determination of the aetiologies of colitis and classification into one of the following categories (in %): infectious colitis (bacterial, parasitic or viral), chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease, other), ischemic colitis and iatrogenic colitis (non-steroidal anti-inflammatory drugs, other). In first intention, the routine microbiological examination of the stools usually performed (PCR assay looking for Shigella spp., Salmonella spp. and Campylobacter spp.; PCR for Clostridium difficile as well as cultures for Vibrio spp. and Yersinia spp. (in option)) will be completed with a high-sensitivity multi-array PCR assay (FilmArray). If the routine microbiological examination of the stools yields to the absence of a potential pathogen, a colonoscopy will be performed to look for: 1) a tumour, 2) a chronic inflammatory bowel disease, or 3) an ischaemic colitis. Patients in whom no aetiology can be found will be given a diagnosis of indeterminate colitis.

  <24 hours

Secondary Outcomes (1)

• Identification of anamnestic, clinical and biological predicting factors for patients requiring diagnostic colonoscopy

  <24 hours and at 1 year

Study Arms (1)

Patients with CT-diagnosed acute colitis

Patients with symptomatic colitis (fever and/or pain and/or diarrhea) proven by computed tomography

Diagnostic Test: Diagnostic

Interventions

Diagnostic DIAGNOSTIC_TEST

Determination of pathogens and faecal calprotectin in the stools

Also known as: Stools: Faecal calprotectin, Stools: FilmArray GI panel (PCR multi-array)

Patients with CT-diagnosed acute colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted at the Emergency Department with a first diagnosis of computed tomography-diagnosed acute colitis

You may qualify if:

• ≥18 year old
• French speaking
• Informed consent
• ≥1 symptom compatible with an acute colitis (fever≥38°C ± acute abdominal pain ± diarrhoea) + colon wall thickening at computed tomography

You may not qualify if:

• Another diagnostic evoked by the radiologist (diverticulitis, tumor, ...)
• Patient with a positive history for: chronic inflammatory bowel disease ± colorectal cancer ± immunosuppression ± abdominal ascites
• Refusal of investigations

Sponsors & Collaborators

• University Hospital, Geneva: lead
• BioMérieux: collaborator

Study Sites (1)

University Hospitals of Geneva

Geneva, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stools

MeSH Terms

Conditions

Colitis; Colorectal Neoplasms

Interventions

Diagnosis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases

Study Officials

• Jeremy Meyer, MD-PhD

  University Hospitals of Geneva, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD-PhD

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 16, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)