Clinical trial NCT03753425: National Multicentric Observatory of Low Bowel Preparations in Patients With IBD
Official title: Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease
Keywords: Inflammatory bowel disease
colonoscopy
bowel preparations
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an indication of colonoscopy independent from the study

Brief summary: National multicentric observatory of low bowel preparations in patients with IBD

Detailed description: Prospective french multicentre observational study, during one month: from March 6th to April 6th 2017, under the auspice of the IBD group of the Société Française d'Endoscopie Digestive- SFED. All French gastroenterologists in charge of IBD patients in public or private endoscopy centers were reached out through various professional and scientific associations to participate in the study via e-mail, web sites, and national congresses. Investigators were asked to prescribe the bowel preparation independently from the study, as per their usual habits. The achievement of low residue diet, the split and the timing of the preparation were left free to the investigator according to local protocols.

Data recording The physicians participating in the study completed data on an online questionnaire via an internet-based tool (CleanWeb software, hosted by Besançon university hospital research center) or through a questionnaire sheet. The questionnaire included a medical record and a self-reported patient questionnaire. The medical record included physicians and centers characteristics, patient's demographics, disease characteristics, modality of bowel preparation (diet, split dose, type of bowel preparation, delay before colonoscopy), and colonoscopy findings and outcomes. Patients self-administered questionnaires assessed preparation tolerability by symptoms and satisfaction recording.

Clinical endpoints The efficacy of the preparation was evaluated by the Boston's score (efficacy was defined as a Boston's score was ≥ 7 without any segment \<2)23, the rate of caecal or anastomosis intubation and the necessity or not to repeat the colonoscopy.

The tolerance was evaluated by the quantity of preparation actually absorbed by the patient, (quantity of active preparation and quantity of clear liquid), patients and investigators visual analogue scale evaluation of tolerance (VAS), a self-administered validated bowel-preparation tolerability questionnaire 24 and by the patients' wish to take the same preparation for the next colonoscopy.

Safety data: adverse events were collected per preparation and per endoscopic procedure, at 24 hours and 30 days later. A special focus was made on aphtoid lesions as they were previously reported as adverse preparation-induced mucosal lesions possibly associated with some solutions.

Eligibility criteria: Inclusion Criteria:

* Patient aged 18-75 years,
* symptoms of IBD for at least 3 month,
* inidcation of colonoscopy independent from the study.

Exclusion Criteria:

* Congestive heart failure,
* severe renal failure,
* gastro intestinal symptomatic obstruction or occlusive bowel stenosis (a non-occlusive stenosis was not an exclusion criterion),
* severe acute colitis,
* severe dehydration or electrolyte disturbances,
* patient's refusal to participate in the study.

Primary outcomes:
measure: Boston Score
timeFrame: 30 days
Secondary outcomes:
measure: tolerance: visual analogue scale
timeFrame: 30 days
measure: adverse events per procedure
timeFrame: 30 days
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hosptalier Universitaire
Study officials:
References: