Routine ColonoscopyNCT01626196
Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation
An observational study of Routine Colonoscopy, run by Norgine at 1 site in Italy.
Trial summary
Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing. This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Routine Colonoscopy
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Jun 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients invited for routine colonoscopy were invited to participate in hte study.
Who may be able to join
- Written informed consent obtained prior to inclusion.
- Male and female outpatients, aged ≥ 18, treated with bowel cleansing preparation the day before undergoing routine colonoscopy at selected participating centres.
Who cannot join
- Children and adolescents aged less than 18 years. Pregnant or breastfeeding women.
- Listed contra-indications to the relevant product used for the bowel cleansing procedure.
- Patients having been submitted to a previous colonoscopy over the last five years.
- Patients who have taken laxative enemas the day preceding the colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre, Observational, Prospective Study, Conducted on Italian Out-patients Undergoing Colonoscopy, for the Evaluation of the Main Determinants of the Patient's Acceptability of Bowel Cleansing Procedure, and of the Success of Bowel Cleansing and Caecal Intubation
Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing.
This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).
- Conditions
- Routine Colonoscopy
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This was an observational study
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy patients | Patients undergoing with bowel cleansing procedures according to the clinics' usual routine Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients acceptability of the procedure
Measured: One day
Secondary outcomes (2)
Time to reach the caecum
Measured: One day
Adenoma detection rate
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Routine ColonoscopyStudies 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norgine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Repici, MD, Principal investigator, Instituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626196
- Sponsor's protocol ID
- NIT MOV 1002
- Status last verified
- Jul 2012
- First submitted
- 20 Jun 2012
- Last updated
- 11 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Observational, Prospective Study, Conducted on Italian Out-patients Undergoing Colonoscopy, for the Evaluation of the Main Determinants of the Patient's Acceptability of Bowel Cleansing Procedure, and of the Success of Bowel Cleansing and Caecal Intubation
- ClinicalTrials.gov ID
- NCT01626196
- Acronym / sponsor ID
- NIT MOV 1002
- Conditions
- Routine Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- NorgineIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 22 Jun 2012 (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.
Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing.
This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy patients | – | Other: No interventionPatients undergoing with bowel cleansing procedures according to the clinics' usual routine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients invited for routine colonoscopy were invited to participate in hte study.
Key inclusion criteria (2 listed)
- Written informed consent obtained prior to inclusion.
- Male and female outpatients, aged ≥ 18, treated with bowel cleansing preparation the day before undergoing routine colonoscopy at selected participating centres.
Key exclusion criteria (4 listed)
- Children and adolescents aged less than 18 years. Pregnant or breastfeeding women.
- Listed contra-indications to the relevant product used for the bowel cleansing procedure.
- Patients having been submitted to a previous colonoscopy over the last five years.
- Patients who have taken laxative enemas the day preceding the colonoscopy.
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 |
|---|---|---|
| No interventionThis was an observational study | Other | Colonoscopy patients |
Primary outcome
Patients acceptability of the procedure
Time frame: One day
2 secondary outcomes
Time to reach the caecum
Time frame: One day
Adenoma detection rate
Time frame: One day
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 11 Jul 2012.
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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.
Alessandro Repici, MD principal investigator
Instituto Clinico Humanitas
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 Routine Colonoscopy, run by Norgine at 1 site in Italy.
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 2 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: finished, as of the sponsor's last update on 11 Jul 2012. 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 Italy. 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?
Patients acceptability of the procedure (time frame: One day). 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 11 Jul 2012.