Colon PolypsNCT01487356
Factors Associated With Short Withdrawal Time and Polyp Detection Rate During Colonoscopy
An observational study of Colon Polyps, run by University of British Columbia at 1 site in Canada.
Trial summary
Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Polyps
- How many people
- 802 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Jun 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.
Who may be able to join
- All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.
Who cannot join
- Exclusion criteria were prior colon resection and repeat colonoscopy for the purpose of endoscopic therapy for known lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study. By collecting data on hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.
Read the detailed description
Background:
Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study.
Objective:
To identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.
Design:
Data were prospectively collected (05/08-06/09) on 802 colonoscopies conducted by 9 blinded endoscopists, including patient age and sex, indication, colonoscope insertion and withdrawal time, biopsies performed, number/size of polyps and method of resection, bowel preparation quality, time of day, day of week, endoscopist, position of the procedure within the endoscopist's slate, and call status of the endoscopist.
Setting:
This study was conducted at a single tertiary care hospital, St. Paul's Hospital, in Vancouver, British Columbia.
- Conditions
- Colon Polyps
- Being tested
- No intervention
- Keywords
- Colonoscopy, quality assurance, withdrawal time, polyp detection rate
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Colonoscopies were conducted as per the endoscopist's usual practice. No change in protocol was expected.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing colonoscopy | Data was collected on all adult patients undergoing outpatient colonoscopy at St. Paul's Hospital from May 2008 to June 2009. Exclusion criteria were prior colon resection and repeat colonoscopy for the purpose of endoscopic therapy for known lesions. Receives: Other: No intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2011 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Time perspective
- Prospective
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rob Enns, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01487356
- Sponsor's protocol ID
- H10-00312
- Status last verified
- Dec 2011
- First submitted
- 3 Aug 2011
- Last updated
- 7 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Short Withdrawal Time and Polyp Detection Rate During Colonoscopy
- ClinicalTrials.gov ID
- NCT01487356
- Acronym / sponsor ID
- H10-00312
- Conditions
- Colon Polyps
- Keywords
- Colonoscopy, quality assurance, withdrawal time, polyp detection rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Dec 2011 (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.
Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study. By collecting data on hundreds of colonoscopies performed by 9 endoscopists, our goal was to identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.
Detailed description
Background:
Colonoscopy withdrawal times are a critical element in determining quality of colonoscopy; however, few studies have evaluated specific factors that may influence the duration of withdrawal, and specifically short withdrawal times. Other factors affecting polyp detection rate, one element of quality of colonoscopy, also need further study.
Objective:
To identify factors associated with withdrawal time, inappropriately short withdrawal times, and polyp detection rate during colonoscopy.
Design:
Data were prospectively collected (05/08-06/09) on 802 colonoscopies conducted by 9 blinded endoscopists, including patient age and sex, indication, colonoscope insertion and withdrawal time, biopsies performed, number/size of polyps and method of resection, bowel preparation quality, time of day, day of week, endoscopist, position of the procedure within the endoscopist's slate, and call status of the endoscopist.
Setting:
This study was conducted at a single tertiary care hospital, St. Paul's Hospital, in Vancouver, British Columbia.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing colonoscopy | – | Other: No interventionData was collected on all adult patients undergoing outpatient colonoscopy at St. Paul's Hospital from May 2008 to June 2009. Exclusion criteria were prior colon resection and repeat colonoscopy for the purpose of endoscopic therapy for known lesions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.
Key inclusion criteria (1 listed)
- All adult patients undergoing colonoscopy at St. Paul's Hospital in Vancouver, BC.
Key exclusion criteria (1 listed)
- Exclusion criteria were prior colon resection and repeat colonoscopy for the purpose of endoscopic therapy for known lesions.
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 interventionColonoscopies were conducted as per the endoscopist's usual practice. No change in protocol was expected. | Other | Patients undergoing colonoscopy |
Primary outcome
Not reported in the source record.
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 7 Dec 2011.
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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.
Rob Enns, MD principal investigator
University of British Columbia
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 Colon Polyps, run by University of British Columbia at 1 site in Canada.
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 1 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 7 Dec 2011. 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 Canada. 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.
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 7 Dec 2011.