National Multicentric Observatory of Low Bowel Preparations in Patients With IBD (CLEAN)

Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases

National multicentric observatory of low bowel preparations in patients with IBD

Study Overview

• Status: Completed
• Conditions: Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease
• Intervention / Treatment: Procedure: Low volume bowel preparation in inflammatory bowel diseases

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 Type: Observational
• Enrollment (Actual): 278

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • Centre Hosptalier Universitaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an indication of colonoscopy independent from the study

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PEG4L, four liters polyethylene glycol
PEG2L, two liters polyethylene glycol with ascorbic acid
Pico, sodium picosulfate
NaP, sodium phosphate
MPS, sodium, magnesium and potassium sulphates	Procedure: Low volume bowel preparation in inflammatory bowel diseases; Low volume bowel preparation in inflammatory bowel diseases; Other Names: Preparation in inflammatory bowel diseases given to patients before a coloscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Score	According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tolerance: visual analogue scale	visual analogue scale	30 days
adverse events per procedure	fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare	30 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2017
• Primary Completion (ACTUAL): June 3, 2017
• Study Completion (ACTUAL): June 3, 2017

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (ACTUAL): November 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: colonoscopy; Inflammatory bowel disease; bowel preparations
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: P/2016/310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No