National Multicentric Observatory of Low Bowel Preparations in Patients With IBD

Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease Clinical Trial

— CLEAN  

Official title:

Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753425
• Other study ID #: P/2016/310
• Status: Completed
• Start date: March 2, 2017
• Est. completion date: June 3, 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

National multicentric observatory of low bowel preparations in patients with IBD

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: June 3, 2017
• Est. primary completion date: June 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease

Intervention

Procedure:
• Low volume bowel preparation in inflammatory bowel diseases
Low volume bowel preparation in inflammatory bowel diseases

Locations

Country	Name	City	State
France	Centre Hosptalier Universitaire	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Score	According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination	30 days
Secondary	tolerance: visual analogue scale	visual analogue scale	30 days
Secondary	adverse events per procedure	fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare	30 days