National Multicentric Observatory of Low Bowel Preparations in Patients With IBD

Completed

• Conditions: Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease
• Interventions: Procedure: Low volume bowel preparation in inflammatory bowel diseases

• Registration Number: NCT03753425
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Study Timeline

• Study Start: 2017-03-02
• Primary Completion: 2017-06-03
• Study Completion: 2017-06-03
• Status Verified: 2017-10
• Study First Submitted: 2017-10-19
• Study First Submitted QC: 2018-11-26
• Last Update Submitted: 2018-11-26
• Study First Posted: 2018-11-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MPS, sodium, magnesium and potassium sulphates	Low volume bowel preparation in inflammatory bowel diseases	MPS, sodium, magnesium and potassium sulphates

Primary Outcome Measures

Name	Time	Method
Boston Score	30 days	According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination

Secondary Outcome Measures

Name	Time	Method
tolerance: visual analogue scale	30 days	visual analogue scale
adverse events per procedure	30 days	fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare

Trial Locations

Locations (1)

Centre Hosptalier Universitaire; 🇫🇷 Besançon, France