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ColitisNCT02709213

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

An observational study of Colitis, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colitis
What is being tested?
Diagnostic
How many people
182 participants
Where
1 siteSwitzerland
Study dates
Nov 2016to Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • ≥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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospitals of Geneva

    Geneva

Other trials in Switzerland

About this study

Official title: Colitis Prospective Cohort Study: Determining the Aetiologies of Acute Colitis and Developing a Diagnostic Score to Identify Patients Requiring Specific Investigations

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.

Read the detailed description

Colitis is the generic term that refers to an inflammation of a segment of the colonic tract confirmed by computed tomography. This pathology represents approximately 100-150 admissions per year in the Division of Digestive Surgery of the University Hospitals of Geneva.

The aetiologies of colitis are numerous and include all pathologies having the ability to cause the inflammation and thickening of the colon wall. Colites are classified according to their aetiologies into: infectious colitis (bacterial, parasitic or viral), inflammatory chronic bowel diseases (ulcerative colitis, Crohn's disease, others), ischaemic colitis and iatrogenic colitis (non-steroidal anti-inflammatory drugs, others). The aetiologies of colitis affect therapeutic care, since patients with infectious colitis will improve with appropriate antibiotics, those with inflammatory chronic bowel disease will require the introduction of an immunosuppressive therapy, and those with ischaemic colitis will only need a supportive treatment and a careful evaluation to detect any progression to bowel perforation that would prompt for surgery.

Therefore, numerous investigations are performed to determine the precise aetiology of colitis.

At the University Hospitals of Geneva, as well as in other centres, a microbiological analysis of faeces (routine 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)) are performed in first intention. If these assays yield to the absence of a potential pathogen, a colonoscopy is 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 to explain the colonic inflammation are given a diagnosis of undetermined colitis.

However, the respective prevalences of the different aetiologies of colitis remain surprisingly unknown. Similarly, no diagnostic tool or clinical score allow to quickly determine or at least stratify the exact cause of colitis in patients admitted in the Emergency Ward and to direct them to the appropriate therapeutic care. As a consequence, all patients admitted with a diagnosis of computed tomography-proven colitis are subjected to broad-spectrum antibiotics associated with a 5-10 days hospitalisation for monitoring and investigations. Patients with negative microbiological examination of the stools will benefit from an early colonoscopy, a procedure that carries significant risks of complications and generates high costs. Moreover, the difficulties in the early identification of patients requiring endoscopy for suspected inflammatory chronic bowel disease or cancer may delay or even contribute to miss these diagnoses, especially if the acute phase of inflammatory chronic bowel disease has passed.

Considering the lack of evidences regarding the therapeutic care of colitis, we plan to constitute a cohort of 200 patients admitted for a first episode of computed tomography-proven colitis at the University Hospitals of Geneva. We will collect data related to 1) the history, clinical and para-clinical presentations at admission, 2) the results of the aetiological investigations; and we will complete the investigations by performing 3) a detailed microbiological examination of the stools using an accurate and rapid multi-array PCR assay (FilmArray, Biofire Diagnostics, Salt Lake City, USA), as well as 4) a dosage of faecal calprotectin (a marker of bowel inflammation).

The aims of the present study are to describe the presentation and aetiologies of colitis, and to develop diagnostic methods to guide patients admitted for acute colitis to the appropriate therapeutic care, with the objective to generate savings by shortening hospital stays and by better prescribing additional tests, including colonoscopy. We therefore think that an adequate and early patient stratification has important medical and economical values in this setting.

We expect: 1) to diagnose a higher proportion of infectious colitis than currently reported, and this within a shorter turnaround time, a finding that could serve as a basis to discuss and implement a reduction in the rate of colonoscopies, 2) to identify predicting factors, including faecal calprotectin, which would help distinguishing patients who require an endoscopic evaluation from others, among patients with negative microbiological examination of the stools.

Conditions
Colitis
Being tested
Diagnostic
Keywords
Inflammatory chronic bowel disease, ICBD, Colorectal cancer, Infectious colitis
Medical subject headings
Colitis, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiagnosticDiagnostic test

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

    Determination of pathogens and faecal calprotectin in the stools

Study groups in NCT02709213
Study groupRoleWhat they receive
Patients with CT-diagnosed acute colitisPatients with symptomatic colitis (fever and/or pain and/or diarrhea) proven by computed tomography
Receives: Diagnostic Test: Diagnostic

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: <24 hours

Secondary outcomes (1)
  1. Identification of anamnestic, clinical and biological predicting factors for patients requiring diagnostic colonoscopy

    Variables related to patients presentation at admission will be detailed and collected, regarding anamnesis, clinical examination and para-clinical exams. Results of the investigations performed during hospitalization will be collected (microbiological examination of the stools, colonoscopy). Faecal calprotectin will be determined for all stool samples. The Geneva Tumour Registry will be searched for the occurrence of tumour at the site of colitis at 1 year after the initial diagnosis. Predictors of "positive" colonoscopy (inflammatory bowel disease, cancer) will be identified using univariate and multivariate logistic regression, analysing variables collected at admission and faecal calprotectin.

    Measured: <24 hours and at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02709213
Sponsor's protocol ID
14-211
Status last verified
Mar 2020
First submitted
2 Mar 2016
Last updated
13 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination of the aetiologies of colitis using microbiological examination of the stools +/- colonoscopy (time frame: <24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.

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