Patient With an Indication of Colonoscopy for Inflammatory Bowel DiseaseCLEANNCT03753425
National Multicentric Observatory of Low Bowel Preparations in Patients With IBD
An observational study of Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
National multicentric observatory of low bowel preparations in patients with IBD Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease
- What is being tested?
- Low volume bowel preparation in inflammatory bowel diseases
- Type of treatment
- Surgery or procedure
- How many people
- 278 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2017to 3 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication of colonoscopy independent from the study
Who may be able to join
- Patient aged 18-75 years,
- symptoms of IBD for at least 3 month,
- inidcation of colonoscopy independent from the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases
National multicentric observatory of low bowel preparations in patients with IBD
Read the 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.
- Being tested
- Low volume bowel preparation in inflammatory bowel diseases
- Keywords
- Inflammatory bowel disease, colonoscopy, bowel preparations
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low volume bowel preparation in inflammatory bowel diseasesProcedure or surgery
Also called Preparation in inflammatory bowel diseases given to patients before a coloscopy
Low volume bowel preparation in inflammatory bowel diseases
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Low volume bowel preparation in inflammatory bowel diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Score
According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination
Measured: 30 days
Secondary outcomes (2)
tolerance: visual analogue scale
visual analogue scale
Measured: 30 days
adverse events per procedure
fever, bowel perforation, bleeding, inhalation, hospitalisation, disease flare
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start2 Mar 2017
- Primary completion3 Jun 2017
- Study completion3 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With an Indication of Colonoscopy for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753425
- Sponsor's protocol ID
- P/2016/310
- Acronym
- CLEAN
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy With Low Volume bowEl prepAration in iNflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT03753425
- Acronym / sponsor ID
- CLEAN / P/2016/310
- Keywords
- Inflammatory bowel disease, colonoscopy, bowel preparations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 2 Mar 2017 (actual)
- Primary completion
- 3 Jun 2017 (actual)
- Study completion
- 3 Jun 2017 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Procedure: Low volume bowel preparation in inflammatory bowel diseasesMPS, sodium, magnesium and potassium sulphates |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication of colonoscopy independent from the study
Key inclusion criteria (3 listed)
- Patient aged 18-75 years,
- symptoms of IBD for at least 3 month,
- inidcation of colonoscopy independent from the study.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low volume bowel preparation in inflammatory bowel diseasesAlso: Preparation in inflammatory bowel diseases given to patients before a coloscopyLow volume bowel preparation in inflammatory bowel diseases | Procedure or surgery | MPS, sodium, magnesium and potassium sulphates |
Primary outcome
Boston Score
Time frame: 30 days
According to the rate of complete colonoscopy (caecal intubation); and according to the need to reschedule the examination
2 secondary outcomes
tolerance: visual analogue scale
Time frame: 30 days
adverse events per procedure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient With an Indication of Colonoscopy for Inflammatory Bowel Disease, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Boston Score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.