Adenomatous Polyp of ColonNCT02538406
The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate.
An observational study of Adenomatous Polyp of Colon, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenomatous Polyp of Colon
- What is being tested?
- Segmental withdrawal
- How many people
- 232 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 2 Apr 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from patients ages 18-80 scheduled for a screening colonoscopy at Baylor College of Medicine. Informed consent will be obtained from the patients during their Gastroenterology clinic visit if the procedure scheduled by gastroenterologist or during their pre-procedure assessment appointment if they were referred by a primary care doctor. Participation in the study will be voluntary. We use the split prep protocol in preparation for colonoscopy in all patients undergoing colonoscopy in our unit.
Who may be able to join
- Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.
Who cannot join
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial.
Colonoscopy( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.
Read the detailed description
Screening colonoscopy is an essential diagnostic tool in the early detection of precancerous colonic lesions, preventing the progression of these lesions to cancer. Population-based and case control studies found a 50% reduction in colo-rectal cancer (CRC) incidence and up to a one-third reduction in mortality from CRC after screening colonoscopy. The effectiveness of colonoscopy in preventing colon cancer is dependent on the adenoma detection rate (ADR) during the procedure. Studies have demonstrated that withdrawal times of 6 minutes or more had higher rates of detection of any neoplasia. In 2006 joint task force of the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy changed the recommendation to indicate that average withdrawal time should exceed 6 minutes in normal colonoscopies in which no polypectomies or biopsies were performed. Based on this recommendation, the 6-minute benchmark is the current standard of care. Longer mean withdrawal times are associated with increasing adenoma detection, mainly of small or right-sided adenomas and proximal serrated adenomas, presumably due to longer inspection of the right colon. However, it also have been showed withdrawal time using 6 minutes as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator. New CRC diagnosis within 3 years of negative screening colonoscopy can be as high as 6%. Right-sided lesions, flat polyps, and variability in endoscopist quality measures are all potential reasons why interval cancers develop. A recent observational study was published showing increase in ADR after implementation of a protocol of careful inspection during a minimum of 8 minutes was established. The investigators hypothesized that if colonoscopists would spend at least half of the time of the withdrawal time in the right side of the colon (referred as segmented protocol), ADR can increase mainly due to the detection of lesions in the right side, which could have been missed otherwise. The investigators are conducting a single center randomized trial investigating the utility of timed segmental withdrawal of at least 3 minutes each in both right and left side of the colon respectively, compared to the regular 6 minutes total withdrawal time regardless of where the time was spent in the colon.
- Conditions
- Adenomatous Polyp of Colon
- Being tested
- Segmental withdrawal
- Keywords
- Adenoma, withdrawal time, Colonoscopy
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Segmental withdrawalOther
Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.
| Study group | Role | What they receive |
|---|---|---|
| non segmental withdrawal | A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon. | |
| Segmental withdrawal | A standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes) Receives: Other: Segmental withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in detection rate of adenomas in the right side of the colon
To determine if timed segmental withdrawal protocol can increase the adenoma detection rate in the right side of the colon compared to non segmental withdrawal.
Measured: 30 minutes
Secondary outcomes (1)
Sessile Serrated lesion detection rate
Compare sessile serrated lesion detection rate between patients undergoing a screening colonoscopy with segmental withdrawal protocol and non-segmental withdrawal protocol.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJun 2020 (estimated)
- Study completion2 Apr 2020
Why it stopped: Local IRB in process to close down study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenomatous Polyp of ColonStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Othman, Baylor College of Medicine
- Investigators
- Mohamed O. Othman, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538406
- Sponsor's protocol ID
- H-37320
- Status last verified
- Oct 2020
- First submitted
- 31 Aug 2015
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Time Segmental Withdrawal During Screening Colonoscopy for Increasing Adenoma Detection Rate. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT02538406
- Acronym / sponsor ID
- H-37320
- Conditions
- Adenomatous Polyp of Colon
- Keywords
- Adenoma, withdrawal time, Colonoscopy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Local IRB in process to close down study.
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jun 2020 (estimated)
- Study completion
- 2 Apr 2020 (actual)
- First posted
- 2 Sep 2015 (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( examining the colon with a flexible tube and a camera ) is usually done for screening purposes to find any precancerous lesions (polyps) at an early stage. During the colonoscopy the doctor will advance the colonoscope to the end of your colon and start examining the colon for any polyps. "Withdrawal time" is the period of time the doctor spends examining the colon. Doctors usually spend six minutes examining the colon after they reach the end of the colon. Studies have showed that spending more withdrawal time detects more lesions. The proposal to dedicating half of the withdrawal time during colonoscopy in examining the right side will increase the detection of polyps in the right side of the colon. There will be no other changes in the procedural aspect of the colonoscopy.
Detailed description
Screening colonoscopy is an essential diagnostic tool in the early detection of precancerous colonic lesions, preventing the progression of these lesions to cancer. Population-based and case control studies found a 50% reduction in colo-rectal cancer (CRC) incidence and up to a one-third reduction in mortality from CRC after screening colonoscopy. The effectiveness of colonoscopy in preventing colon cancer is dependent on the adenoma detection rate (ADR) during the procedure. Studies have demonstrated that withdrawal times of 6 minutes or more had higher rates of detection of any neoplasia. In 2006 joint task force of the American College of Gastroenterology and American Society for Gastrointestinal Endoscopy changed the recommendation to indicate that average withdrawal time should exceed 6 minutes in normal colonoscopies in which no polypectomies or biopsies were performed. Based on this recommendation, the 6-minute benchmark is the current standard of care. Longer mean withdrawal times are associated with increasing adenoma detection, mainly of small or right-sided adenomas and proximal serrated adenomas, presumably due to longer inspection of the right colon. However, it also have been showed withdrawal time using 6 minutes as the threshold is not a strong predictor of the likelihood of finding a polyp during colonoscopy and should not be used as a quality indicator. New CRC diagnosis within 3 years of negative screening colonoscopy can be as high as 6%. Right-sided lesions, flat polyps, and variability in endoscopist quality measures are all potential reasons why interval cancers develop. A recent observational study was published showing increase in ADR after implementation of a protocol of careful inspection during a minimum of 8 minutes was established. The investigators hypothesized that if colonoscopists would spend at least half of the time of the withdrawal time in the right side of the colon (referred as segmented protocol), ADR can increase mainly due to the detection of lesions in the right side, which could have been missed otherwise. The investigators are conducting a single center randomized trial investigating the utility of timed segmental withdrawal of at least 3 minutes each in both right and left side of the colon respectively, compared to the regular 6 minutes total withdrawal time regardless of where the time was spent in the colon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non segmental withdrawal | – | –A standard of care colonoscopy will be done on the patient without extra time on the right side of the colon. |
| Segmental withdrawal | – | Other: Segmental withdrawalA standard of care colonoscopy will be done on the patient , however the time spent in the right side of the colon will be more than half of the normal colonoscopy procedure (i.e. more than 3 minutes) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from patients ages 18-80 scheduled for a screening colonoscopy at Baylor College of Medicine. Informed consent will be obtained from the patients during their Gastroenterology clinic visit if the procedure scheduled by gastroenterologist or during their pre-procedure assessment appointment if they were referred by a primary care doctor. Participation in the study will be voluntary. We use the split prep protocol in preparation for colonoscopy in all patients undergoing colonoscopy in our unit.
Key inclusion criteria (1 listed)
- Adult patients (18-80 years) who are undergoing colonoscopy for screening or surveillance purposes.
Key exclusion criteria (5 listed)
- Patients with a prior history of colonic surgeries
- Patient with Crohns colitis or ulcerative colitis
- Patient with prior history of colon cancer
- Patient with poor bowel preparation
- Pregnant women
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 |
|---|---|---|
| Segmental withdrawalInterventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal. | Other | Segmental withdrawal |
Primary outcome
Increase in detection rate of adenomas in the right side of the colon
Time frame: 30 minutes
To determine if timed segmental withdrawal protocol can increase the adenoma detection rate in the right side of the colon compared to non segmental withdrawal.
1 secondary outcome
Sessile Serrated lesion detection rate
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: Local IRB in process to close down study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
Mohamed O. Othman, MD principal investigator
Baylor College of Medicine
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 Adenomatous Polyp of Colon, run by Baylor College of Medicine at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 28 Oct 2020. 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 United States. 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 was stopped early (reason given: Local IRB in process to close down study.). Results are not available in the source record.
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?
Increase in detection rate of adenomas in the right side of the colon (time frame: 30 minutes). 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 28 Oct 2020.