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Trial record 51 of 243919 for:    Diseases

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03753425
Recruitment Status : Completed
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment
Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease 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.

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Study Type : Observational
Actual Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases
Actual Study Start Date : March 2, 2017
Actual Primary Completion Date : June 3, 2017
Actual Study Completion Date : June 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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

Primary Outcome Measures :
  1. Boston Score [ Time Frame: 30 days ]
    According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination

Secondary Outcome Measures :
  1. tolerance: visual analogue scale [ Time Frame: 30 days ]
    visual analogue scale

  2. adverse events per procedure [ Time Frame: 30 days ]
    fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with an indication of colonoscopy independent from the study

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03753425

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Centre Hosptalier Universitaire
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon Identifier: NCT03753425     History of Changes
Other Study ID Numbers: P/2016/310
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Inflammatory bowel disease
bowel preparations

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Ascorbic Acid
Picosulfate sodium
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances
Gastrointestinal Agents