Colonic PolypADRNCT03908229
Trainee Participation Increases Colon Adenoma Detection Rate
A study testing Trainee colonoscopy and Experienced physician colonoscopy in people with Colonic Polyp, run by Ospedali Riuniti di Foggia at 4 sites in Italy.
Trial summary
Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- Trainee colonoscopy and Experienced physician colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 4 sitesItaly
- Study dates
- 5 Apr 2019to 10 Jan 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing colonoscopy.
Who cannot join
- Age under 18 years
- Familial history of polyposis syndrome (familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, juvenile polyposis).
- Incomplete colonoscopy
- Inflammatory bowel disease
- Refusal to provide informed consent.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Ospedale di Brindisi
Brindisi, 71122
Ospedali Riuniti Foggia
Foggia, 71122
Ospedale di San Severo
San Severo, Out of USA Or Canada, 71122
Ospedale di Taranto
Taranto, Out of USA Or Canada, 71122
About this study
Official title: Trainee Participation Increases Colon Adenoma Detection Rate: a Randomized Controlled Trial
Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well-designed randomized controlled trials are lacking.
The study objective is to examine whether fellow participation during screening, surveillance, or diagnostic colonoscopy influence overall, size-specific, or location-specific adenoma or polyp detection rate.
It will be planned to enroll 812 patients (406 per arms) within 1 year. Adenoma detection rate will be the primary outcome.
Read the detailed description
Background Colonoscopy is instrumental in colon cancer prevention as through polypectomy it may interfere with the adenoma-carcinoma sequence, thus resulting in a clear survival benefit.
However, not all adenomatous polyps are identified during a colonoscopy. The overall false-negative ("miss") rate for colonic adenomas is estimated to be as high as 24%, according to studies of same-day, tandem colonoscopies. In addition, flat and depressed lesions often remain undetected during white-light colonoscopy.
Low-cost optimization of existing resources, such as use of a second observer or water-aided colonoscopy, were recently found to be able to significantly increase colon adenoma detection rate (ADR).
Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well-designed randomized controlled trials (RCTs) are lacking.
.
Technical procedure In the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations.
In the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending.
During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions.
Colonoscopies will be performed by using only high-definition white-light (HDWL) scopes (Olympus 180 series CF H180).
Bowel preparation will be uniform and consist of 4 L of polyethylene glycol. All detected lesions will be endoscopically removed and samples will be sent to pathologists for histological diagnosis.
Treatment strategy Patients complying with the eligibility criteria will be randomized in a 1:1 fashion to undergo colonoscopy performed by a trainee (under attending physician supervision) or colonoscopy performed by an experienced physician.
Sample size calculation and statistical considerations On the basis of previous retrospective comparative reports, the study is designed to detect an increase in ADR by 8%. Therefore, 812 patients (406 per arm) will be required to have a 80% power to detect the target difference at a 0.05 significance level (two sided). The primary endpoint will be ADR. In order to collect the estimated sample size, up to 1 year of recruiting will be needed.
- Conditions
- Colonic Polyp
- Being tested
- Trainee colonoscopy, Experienced physician colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trainee colonoscopyProcedure or surgery
Colonoscopy performed by trainee
Experienced physician colonoscopyProcedure or surgery
Experienced physician colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Trainee colonoscopy | Experimental | In the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending.
During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions. Receives: Procedure: Trainee colonoscopy |
| Experienced physician colonoscopy | Active comparator | In the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations. Receives: Procedure: Experienced physician colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: 12 months
Secondary outcomes (4)
Advanced adenoma detection rate
Measured: 12 months
Polyp detection rate
Measured: 12 months
Sessile serrated adenoma detection rate
Measured: 12 months
Adenoma per colonoscopy rate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start5 Apr 2019
- Primary completion10 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedali Riuniti di Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Facciorusso, Ospedali Riuniti di Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908229
- Sponsor's protocol ID
- ADR01
- Acronym
- ADR
- Status last verified
- Mar 2020
- First submitted
- 6 Apr 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. doi: 10.1111/j.1572-0241.2003.07662.x.
PubMed 14499778Rex DK. Maximizing detection of adenomas and cancers during colonoscopy. Am J Gastroenterol. 2006 Dec;101(12):2866-77. doi: 10.1111/j.1572-0241.2006.00905.x.
PubMed 17227527Facciorusso A, Triantafyllou K, Murad MH, Prokop LJ, Tziatzios G, Muscatiello N, Singh S. Compared Abilities of Endoscopic Techniques to Increase Colon Adenoma Detection Rates: A Network Meta-analysis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2439-2454.e25. doi: 10.1016/j.cgh.2018.11.058. Epub 2018 Dec 6.
PubMed 30529731Gianotti RJ, Oza SS, Tapper EB, Kothari D, Sheth SG. A Longitudinal Study of Adenoma Detection Rate in Gastroenterology Fellowship Training. Dig Dis Sci. 2016 Oct;61(10):2831-2837. doi: 10.1007/s10620-016-4228-9. Epub 2016 Jul 12.
PubMed 27405989Nishizawa T, Suzuki H, Takahashi M, Kaneko H, Fujiyama Y, Komatsu H, Nagumo H, Tanaka S, Hibi T. Trainee participation during colonoscopy adversely affects polyp and adenoma detection rates. Digestion. 2011;84(3):245-6. doi: 10.1159/000330736. Epub 2011 Sep 7. No abstract available.
PubMed 21912131Buchner AM, Shahid MW, Heckman MG, Diehl NN, McNeil RB, Cleveland P, Gill KR, Schore A, Ghabril M, Raimondo M, Gross SA, Wallace MB. Trainee participation is associated with increased small adenoma detection. Gastrointest Endosc. 2011 Jun;73(6):1223-31. doi: 10.1016/j.gie.2011.01.060. Epub 2011 Apr 8.
PubMed 21481861Facciorusso A, Buccino VR, Tonti P, Licinio R, Del Prete V, Neve V, Di Maso M, Muscatiello N. Impact of fellow participation on colon adenoma detection rates: a multicenter randomized trial. Gastrointest Endosc. 2020 Dec;92(6):1228-1235. doi: 10.1016/j.gie.2020.05.015. Epub 2020 May 17.
PubMed 32433915
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trainee Participation Increases Colon Adenoma Detection Rate: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03908229
- Acronym / sponsor ID
- ADR / ADR01
- Conditions
- Colonic Polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Ospedali Riuniti di FoggiaUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 9 Apr 2019 (actual)
- 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.
Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well-designed randomized controlled trials are lacking.
The study objective is to examine whether fellow participation during screening, surveillance, or diagnostic colonoscopy influence overall, size-specific, or location-specific adenoma or polyp detection rate.
It will be planned to enroll 812 patients (406 per arms) within 1 year. Adenoma detection rate will be the primary outcome.
Detailed description
Background Colonoscopy is instrumental in colon cancer prevention as through polypectomy it may interfere with the adenoma-carcinoma sequence, thus resulting in a clear survival benefit.
However, not all adenomatous polyps are identified during a colonoscopy. The overall false-negative ("miss") rate for colonic adenomas is estimated to be as high as 24%, according to studies of same-day, tandem colonoscopies. In addition, flat and depressed lesions often remain undetected during white-light colonoscopy.
Low-cost optimization of existing resources, such as use of a second observer or water-aided colonoscopy, were recently found to be able to significantly increase colon adenoma detection rate (ADR).
Previous studies that examined whether the presence of an additional observer, more specifically a GI fellow, during colonoscopy can enhance detection of all polyps and adenomas yielded conflicting results. Of note, all of the aforementioned studies were retrospective and robust evidence derived from well-designed randomized controlled trials (RCTs) are lacking.
.
Technical procedure In the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations.
In the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending.
During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions.
Colonoscopies will be performed by using only high-definition white-light (HDWL) scopes (Olympus 180 series CF H180).
Bowel preparation will be uniform and consist of 4 L of polyethylene glycol. All detected lesions will be endoscopically removed and samples will be sent to pathologists for histological diagnosis.
Treatment strategy Patients complying with the eligibility criteria will be randomized in a 1:1 fashion to undergo colonoscopy performed by a trainee (under attending physician supervision) or colonoscopy performed by an experienced physician.
Sample size calculation and statistical considerations On the basis of previous retrospective comparative reports, the study is designed to detect an increase in ADR by 8%. Therefore, 812 patients (406 per arm) will be required to have a 80% power to detect the target difference at a 0.05 significance level (two sided). The primary endpoint will be ADR. In order to collect the estimated sample size, up to 1 year of recruiting will be needed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainee colonoscopy | Experimental | Procedure: Trainee colonoscopyIn the investigation arm colonoscopy will be performed by gastroenterology fellows. The fellows will always start the case and proceed generally until they are unable to make further progress despite "coaching" from the staff attending. During the procedures with fellows, the staff attending will always actively participate in the entire procedure and assess for the presence of any lesions. |
| Experienced physician colonoscopy | Active comparator | Procedure: Experienced physician colonoscopyIn the control arm all colonoscopy will be performed by full-time board-certified gastroenterologists who have each done more than 5000 colonoscopy examinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing colonoscopy.
Key exclusion criteria (5 listed)
- Age under 18 years
- Familial history of polyposis syndrome (familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, juvenile polyposis).
- Incomplete colonoscopy
- Inflammatory bowel disease
- Refusal to provide informed consent.
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 |
|---|---|---|
| Trainee colonoscopyColonoscopy performed by trainee | Procedure or surgery | Trainee colonoscopy |
| Experienced physician colonoscopyExperienced physician colonoscopy | Procedure or surgery | Experienced physician colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: 12 months
4 secondary outcomes
Advanced adenoma detection rate
Time frame: 12 months
Polyp detection rate
Time frame: 12 months
Sessile serrated adenoma detection rate
Time frame: 12 months
Adenoma per colonoscopy rate
Time frame: 12 months
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 3 Mar 2020.
- Background: PubMed 14499778Rex DK, Chadalawada V, Helper DJ. Wide angle colonoscopy with a prototype instrument: impact on miss rates and efficiency as determined by back-to-back colonoscopies. Am J Gastroenterol. 2003 Sep;98(9):2000-5. doi: 10.1111/j.1572-0241.2003.07662.x.
- Background: PubMed 17227527Rex DK. Maximizing detection of adenomas and cancers during colonoscopy. Am J Gastroenterol. 2006 Dec;101(12):2866-77. doi: 10.1111/j.1572-0241.2006.00905.x.
- Background: PubMed 30529731Facciorusso A, Triantafyllou K, Murad MH, Prokop LJ, Tziatzios G, Muscatiello N, Singh S. Compared Abilities of Endoscopic Techniques to Increase Colon Adenoma Detection Rates: A Network Meta-analysis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2439-2454.e25. doi: 10.1016/j.cgh.2018.11.058. Epub 2018 Dec 6.
- Background: PubMed 27405989Gianotti RJ, Oza SS, Tapper EB, Kothari D, Sheth SG. A Longitudinal Study of Adenoma Detection Rate in Gastroenterology Fellowship Training. Dig Dis Sci. 2016 Oct;61(10):2831-2837. doi: 10.1007/s10620-016-4228-9. Epub 2016 Jul 12.
- Background: PubMed 21912131Nishizawa T, Suzuki H, Takahashi M, Kaneko H, Fujiyama Y, Komatsu H, Nagumo H, Tanaka S, Hibi T. Trainee participation during colonoscopy adversely affects polyp and adenoma detection rates. Digestion. 2011;84(3):245-6. doi: 10.1159/000330736. Epub 2011 Sep 7. No abstract available.
- Background: PubMed 21481861Buchner AM, Shahid MW, Heckman MG, Diehl NN, McNeil RB, Cleveland P, Gill KR, Schore A, Ghabril M, Raimondo M, Gross SA, Wallace MB. Trainee participation is associated with increased small adenoma detection. Gastrointest Endosc. 2011 Jun;73(6):1223-31. doi: 10.1016/j.gie.2011.01.060. Epub 2011 Apr 8.
- Derived from this study: PubMed 32433915Facciorusso A, Buccino VR, Tonti P, Licinio R, Del Prete V, Neve V, Di Maso M, Muscatiello N. Impact of fellow participation on colon adenoma detection rates: a multicenter randomized trial. Gastrointest Endosc. 2020 Dec;92(6):1228-1235. doi: 10.1016/j.gie.2020.05.015. Epub 2020 May 17.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trainee colonoscopy and Experienced physician colonoscopy in people with Colonic Polyp, run by Ospedali Riuniti di Foggia at 4 sites 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 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: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Adenoma detection rate (time frame: 12 months). 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 NCT03908229, which also lists 7 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 3 Mar 2020.