Colonic PolypsNCT02305251
Patient Preferences of a Resect and Discard Paradigm
An observational study of Colonic Polyps, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The investigators conducted a study "Resect and Discard Diminutive Polyps: a new paradigm" (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Survey
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to 2 Nov 2015
- 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: Patients reporting in for colonoscopies either for screening or for polyp surveillance.
Who may be able to join
- Indication for colonoscopy is screening or routine polyp surveillance
Who cannot join
- Indication for colonoscopy other than screening or surveillance
- Colon cancer identified at time of colonoscopy
- Known polyposis syndrome, or polyposis identified at colonoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
The investigators conducted a study "Resect and Discard Diminutive Polyps: a new paradigm" (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be resected and discarded (instead of being sent to pathology). One of the main advantages of this approach is significant cost savings by reducing pathology costs associated with screening and surveillance colonoscopy. A disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no data regarding patient preferences toward this approach. The investigators therefore designed a patient survey to determine the patient's view toward this approach.
Read the detailed description
The American Society of Gastrointestinal Endoscopy (ASGE) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". This new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "Resect and Discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. This is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations.
Neither the ASGE document nor published research, however, assessed patient attitudes toward this approach. This study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. We also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.
- Conditions
- Colonic Polyps
- Being tested
- Survey
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Standard Gamble Survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.
This outcome is measured in percentage.
Measured: June, 2012 to March, 2014: up to 2 years
Secondary outcomes (1)
The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.
These factors were measured using univariate analysis with generation of odds ratios and 95% confidence intervals.
Measured: June, 2012 to March, 2014: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study startJun 2012
- Primary completionMar 2014
- Study completion2 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies of the same condition, open and under way.
- More trials run by Washington University School 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dayna Early, Washington University School of Medicine
- Investigators
- Dayna S Early, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305251
- Sponsor's protocol ID
- 201202031
- Status last verified
- May 2017
- First submitted
- 19 Nov 2014
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
PubMed 20621680Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
PubMed 19187781Vu HT, Sayuk GS, Gupta N, Hollander T, Kim A, Early DS. Patient preferences of a resect and discard paradigm. Gastrointest Endosc. 2015 Aug;82(2):381-384.e1. doi: 10.1016/j.gie.2015.01.042. Epub 2015 Apr 22.
PubMed 25910663
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences of a Resect and Discard Paradigm
- ClinicalTrials.gov ID
- NCT02305251
- Acronym / sponsor ID
- 201202031
- Conditions
- Colonic Polyps
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- 2 Nov 2015 (actual)
- First posted
- 2 Dec 2014 (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 investigators conducted a study "Resect and Discard Diminutive Polyps: a new paradigm" (IRB ID # 201105473) from September, 2011 to July, 2013. This study examined whether doctors performing colonoscopy are accurate enough at predicting histology of small colorectal polyps, such that these small polyps could be resected and discarded (instead of being sent to pathology). One of the main advantages of this approach is significant cost savings by reducing pathology costs associated with screening and surveillance colonoscopy. A disadvantage is that there is a 0.03% chance that small polyps contain cancer. There is no data regarding patient preferences toward this approach. The investigators therefore designed a patient survey to determine the patient's view toward this approach.
Detailed description
The American Society of Gastrointestinal Endoscopy (ASGE) published a review article on a new paradigm in colorectal cancer screening termed "resect and discard". This new paradigm challenges the current practice of sending all colorectal polyps, regardless of appearance or size, to pathology for analysis. "Resect and Discard" describes a new approach in which small polyps could be removed, but be discarded instead of sent for pathology analysis. This is based on data showing that gastroenterologists can predict the pathology of small colorectal polyps with 80-90% accuracy, and that discarding small polyps would not alter surveillance recommendations.
Neither the ASGE document nor published research, however, assessed patient attitudes toward this approach. This study surveyed patients prior to first time screening colonoscopy, in order to determine their preferences about the resect and discard approach; specifically would patients be willing to pay for pathology analysis of small colorectal polyps with their own money, and what factors influence their decision. We also inquired about factors that would influence their decision to pay/not pay pathology costs themselves.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients reporting in for colonoscopies either for screening or for polyp surveillance.
Key inclusion criteria (1 listed)
- Indication for colonoscopy is screening or routine polyp surveillance
Key exclusion criteria (3 listed)
- Indication for colonoscopy other than screening or surveillance
- Colon cancer identified at time of colonoscopy
- Known polyposis syndrome, or polyposis identified at 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 |
|---|---|---|
| SurveyStandard Gamble Survey | Other | – |
Primary outcome
Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found.
Time frame: June, 2012 to March, 2014: up to 2 years
This outcome is measured in percentage.
1 secondary outcome
The factors that influence patients' decisions to pay or not pay for pathology costs with their own money.
Time frame: June, 2012 to March, 2014: up to 2 years
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 May 2017.
- Background: PubMed 20621680Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
- Background: PubMed 19187781Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
- Derived from this study: PubMed 25910663Vu HT, Sayuk GS, Gupta N, Hollander T, Kim A, Early DS. Patient preferences of a resect and discard paradigm. Gastrointest Endosc. 2015 Aug;82(2):381-384.e1. doi: 10.1016/j.gie.2015.01.042. Epub 2015 Apr 22.
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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.
Dayna S Early, MD principal investigator
Washington University School 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 Colonic Polyps, run by Washington University School 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 3 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 May 2017. 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 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?
Number of participants willing to pay out of pocket for pathology costs when a diminutive polyp is found. (time frame: June, 2012 to March, 2014: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02305251, which also lists 3 linked publications.
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 May 2017.