ColonoscopyPhase 3NCT00160823
Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients
A Phase 3 study testing Self-administered leaflet in people with Colonoscopy, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A hand-out was made to instruct and motivate patients to adequately clean the bowel before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Self-administered leaflet
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2005to not given
- Phase
- Phase 3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total colonoscopy scheduled during hospital stay in the Hôpital Universitaire de Genève (excluding dependencies);
- Informed consent for inclusion in the study signed by the patient;
- Ability to read and write at least one of the following languages : French, English, Spanish, Portuguese.
Who cannot join
- Colonoscopy scheduled under general anesthesia;
- Occupation inside the healthcare professions;
- Previous colonoscopy, colostomy or colectomy;
- Megacolon or idiopathic pseudo-obstruction.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Gastroenterology and Hepatology Division, University Hospital of Geneva
Geneva, 1205
Jean-Marc Dumonceau, MD,PhD, + 41 22 372 93 40, jmdumonceau@hotmail.com
JM Dumonceau, MD,PhD
About this study
Official title: Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital
The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A hand-out was made to instruct and motivate patients to adequately clean the bowel before colonoscopy.
The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients receiving the hand-out or not on the day before colonoscopy.
- Conditions
- Colonoscopy
- Being tested
- Self-administered leaflet
- Keywords
- Colon cleansing, Quality, Cost-effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered leafletProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of overall colon cleansing
Secondary outcomes (6)
Quality of cleansing in the ascending colon,
Frequency of inadequate preparation and of failed procedure,
Time to intubate the caecum,
Cost-effectiveness of the self-administered leaflet,
Patient compliance with the self-administered leaflet,
Patient comfort with the colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 102 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Marc Dumonceau, MD,PhD, Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160823
- Sponsor's protocol ID
- 04-147
- Status last verified
- Sep 2006
- First submitted
- 8 Sep 2005
- Last updated
- 13 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital
- ClinicalTrials.gov ID
- NCT00160823
- Acronym / sponsor ID
- 04-147
- Conditions
- Colonoscopy
- Keywords
- Colon cleansing, Quality, Cost-effectiveness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2005
- First posted
- 12 Sep 2005 (estimated)
- 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.
The quality of colon cleansing has a major impact on efficiency and cost of colonoscopy. A hand-out was made to instruct and motivate patients to adequately clean the bowel before colonoscopy.
The aim of the study is to compare adequacy of bowel cleansing in hospitalized patients receiving the hand-out or not on the day before colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total colonoscopy scheduled during hospital stay in the Hôpital Universitaire de Genève (excluding dependencies);
- Informed consent for inclusion in the study signed by the patient;
- Ability to read and write at least one of the following languages : French, English, Spanish, Portuguese.
Key exclusion criteria (4 listed)
- Colonoscopy scheduled under general anesthesia;
- Occupation inside the healthcare professions;
- Previous colonoscopy, colostomy or colectomy;
- Megacolon or idiopathic pseudo-obstruction.
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 |
|---|---|---|
| Self-administered leaflet | Procedure or surgery | – |
Primary outcome
Quality of overall colon cleansing
6 secondary outcomes
Quality of cleansing in the ascending colon,
Frequency of inadequate preparation and of failed procedure,
Time to intubate the caecum,
Cost-effectiveness of the self-administered leaflet,
Patient compliance with the self-administered leaflet,
Patient comfort with the colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
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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.
Jean-Marc Dumonceau, MD,PhD study chair
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Self-administered leaflet in people with Colonoscopy, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Sep 2006. 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 Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Dumonceau, MD,PhD (+41223729340, jmdumonceau@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of overall colon cleansing. 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 13 Sep 2006.