Colorectal CancerXIMEPEG-RLNCT06319924
Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy
An observational study of Colorectal Cancer and Colonoscopy, run by Hospital St. Joseph, Marseille, France at 5 sites in France.
Trial summary
Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer, Colonoscopy, Bowel Preparation Solution
- What is being tested?
- Simethicone combined with Macrogol 4000 (PEG)
- How many people
- 601 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Feb 2020to 15 Sep 2022
- 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 50 to 75 years
- All sexes
- Adult, Older adult
Study population: All patients, scheduled for colonoscopy as part of CRC screening, were prospectively included according to the inclusion criteria
Who may be able to join
- patients :
- scheduled for colonoscopy as part of CRC screening, using the bowel preparation with fixed low-dose of simethicone combined with Macrogol 4000 (PEG)
- aged 50-75 years,
- with no family history of CRC or personal history of colon polyps but with a positive Faecal Immunochemical Test (FIT), with a family history of CRC or personal history of colon polyps,
- requiring surveillance colonoscopy after 5 years if diagnosed with one or two tubular adenomas <10 mm in diameter (low-risk group) or after 3 years if diagnosed with at least 3 adenomas or any adenoma at least 10 mm in diameter or with high-grade dysplasia, according to French recommendations during the study inclusion period.
Who cannot join
- -
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clinique des Cèdres, Ramsay Santé,
Cornebarrieu, 31700
Polyclinique Louis Pasteur,
Essey-lès-Nancy, 54280
Saint Joseph Hospital
Marseille, 13008
5. Clinique Ambroise Paré
Toulouse, 31082
Pole Santé des Haberges
Vesoul, 70000
About this study
Official title: Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy: Phase 4 Prospective Multicenter Real Life Study
Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.
Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments.
- Conditions
- Colorectal Cancer, Colonoscopy, Bowel Preparation Solution
- Being tested
- Simethicone combined with Macrogol 4000 (PEG)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simethicone combined with Macrogol 4000 (PEG)Drug
bowel preparation product for colonoscopy as part of CRC screening
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the quality of the bowel preparation assessed by Bubble scale
Measured: During procedure
Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)
Measured: During procedure
Secondary outcomes (4)
Colonoscope removal time
time spent by the endoscopist searching for polyps and adenomas (mn)
Measured: immediately post procedure
The frequency of adverse events (AEs)
including nausea, vomiting, abdominal bloating - and their severity,
Measured: within 10 minutes post procedure
volume of bowel preparation ingested
in ml
Measured: immediately post procedure
Caecal intubation rate
successful Caecal intubation
Measured: immediately post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Feb 2020
- Primary completion31 May 2021
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319924
- Sponsor's protocol ID
- XIMEPEG-RL
- Acronym
- XIMEPEG-RL
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Low-dose Simethicone Combined With Macrogol 4000 (PEG) Reduces Colon Bubble Formation in Colonoscopy: Phase 4 Prospective Multicenter Real Life Study
- ClinicalTrials.gov ID
- NCT06319924
- Acronym / sponsor ID
- XIMEPEG-RL / XIMEPEG-RL
- Conditions
- Colorectal Cancer, Colonoscopy, Bowel Preparation Solution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 20 Mar 2024 (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.
Several randomised studies have shown that the addition of low-dose Simethicone to the bowel preparation was sufficient to reduce the presence of bubbles during colonoscopy. The aim of this study was to evaluate the efficacy and safety of a bowel preparation containing low-dose Simethicone on bubble formation.
Patients and Methods This prospective, real-life, phase 4 study was conducted from February 2020 to May 2021, in five private endoscopy centres, among adult patients undergoing a colonoscopy. Clinical, endoscopic and histological parameters were collected on e-CRF. The primary endpoint was the measurement of bubble formation in the various colon segments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients, scheduled for colonoscopy as part of CRC screening, were prospectively included according to the inclusion criteria
Key inclusion criteria (5 listed)
- scheduled for colonoscopy as part of CRC screening, using the bowel preparation with fixed low-dose of simethicone combined with Macrogol 4000 (PEG)
- aged 50-75 years,
- with no family history of CRC or personal history of colon polyps but with a positive Faecal Immunochemical Test (FIT), with a family history of CRC or personal history of colon polyps,
- requiring surveillance colonoscopy after 5 years if diagnosed with one or two tubular adenomas <10 mm in diameter (low-risk group) or after 3 years if diagnosed with at least 3 adenomas or any adenoma at least 10 mm in diameter or with high-grade dysplasia, according to French recommendations during the study inclusion period.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Simethicone combined with Macrogol 4000 (PEG)bowel preparation product for colonoscopy as part of CRC screening | Drug | – |
Primary outcome
Assess the quality of the bowel preparation assessed by Bubble scale
Time frame: During procedure
Assess the quality of the bowel preparation assessed by Boston Bowel Preparation Scale (BBPS)
Time frame: During procedure
4 secondary outcomes
Colonoscope removal time
Time frame: immediately post procedure
The frequency of adverse events (AEs)
Time frame: within 10 minutes post procedure
volume of bowel preparation ingested
Time frame: immediately post procedure
Caecal intubation rate
Time frame: immediately post procedure.
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 20 Mar 2024.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colonoscopy, run by Hospital St. Joseph, Marseille, France at 5 sites 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 5 inclusion and 1 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Assess the quality of the bowel preparation assessed by Bubble scale (time frame: During procedure). The study lists 2 primary outcomes in all. 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 20 Mar 2024.