Colon NeoplasmsNCT02838186
Backwards Examination of the Right Colon: A Back-to-back Study
A study testing retroflexion and forward view in people with Colon Neoplasms, run by Attikon Hospital at 1 site in Greece.
Trial summary
The aim of this study is to evaluate the examination of the proximal colon with the retroflexion colonoscopic technique in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Neoplasms
- What is being tested?
- retroflexion and forward view
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 1 siteGreece
- Study dates
- May 2013to Feb 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective colonoscopy in a Attikon University General Hospital.
Who cannot join
- patients aged <18 and >80 years;
- right colectomy;
- recent abdominalsurgery;
- multiple diverticula of the right colon;
- American Society of Anesthesiology (ASA) physical status classification grade IV;
- inflammatory bowel disease and polyposis syndromes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Yield of Scope Retroflexion in the Right Colon: A Prospective Cohort Study
The aim of this study is to evaluate the examination of the proximal colon with the retroflexion colonoscopic technique in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers.
Read the detailed description
The investigators prospectively examined the additional diagnostic yield of right colon examination with colonoscope retroflexion in consecutive, symptomatic and screening - surveillance patients. Right colon was examined in forward-view first and thereafter, retroflexion was performed to re-inspect it.
- Conditions
- Colon Neoplasms
- Being tested
- retroflexion, forward view
- Keywords
- colonoscopy, right colon retroflexion, adenoma detection rate, feasibility, surveillance interval
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retroflexionProcedure or surgery
examination of the right colon with scope retroflexion
forward viewProcedure or surgery
examination of the right colon in forward view
| Study group | Role | What they receive |
|---|---|---|
| right colon in retroflexion | Active comparator | * polyp/adenoma detection
* feasibility Receives: Procedure: retroflexion |
| right colon in forward view | Active comparator | polyp/adenoma detection Receives: Procedure: forward view |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of additional identified polyps with right colon scope retroflexion
Measured: one week
Secondary outcomes (2)
Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients
change: YES or NO
Measured: one week
Rate of retroflexion-related adverse events.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startMay 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon NeoplasmsStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATHANASIOS SIOULAS, Attikon Hospital
- Investigators
- Konstantinos Triantafyllou, Prof, Study director, Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838186
- Sponsor's protocol ID
- Retro-2013
- Status last verified
- Jul 2016
- First submitted
- 19 Jun 2013
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
PubMed 16454841Vemulapalli KC, Rex DK. Evolving techniques in colonoscopy. Curr Opin Gastroenterol. 2011 Sep;27(5):430-8. doi: 10.1097/MOG.0b013e328349cfc0.
PubMed 21785352
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Yield of Scope Retroflexion in the Right Colon: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02838186
- Acronym / sponsor ID
- Retro-2013
- Conditions
- Colon Neoplasms
- Keywords
- colonoscopy, right colon retroflexion, adenoma detection rate, feasibility, surveillance interval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 20 Jul 2016 (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 aim of this study is to evaluate the examination of the proximal colon with the retroflexion colonoscopic technique in terms of feasibility and its possible additive contribution in the detection of important lesions, namely polyps and cancers.
Detailed description
The investigators prospectively examined the additional diagnostic yield of right colon examination with colonoscope retroflexion in consecutive, symptomatic and screening - surveillance patients. Right colon was examined in forward-view first and thereafter, retroflexion was performed to re-inspect it.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| right colon in retroflexion | Active comparator | Procedure: retroflexion* polyp/adenoma detection * feasibility |
| right colon in forward view | Active comparator | Procedure: forward viewpolyp/adenoma detection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective colonoscopy in a Attikon University General Hospital.
Key exclusion criteria (6 listed)
- patients aged <18 and >80 years;
- right colectomy;
- recent abdominalsurgery;
- multiple diverticula of the right colon;
- American Society of Anesthesiology (ASA) physical status classification grade IV;
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 |
|---|---|---|
| retroflexionexamination of the right colon with scope retroflexion | Procedure or surgery | right colon in retroflexion |
| forward viewexamination of the right colon in forward view | Procedure or surgery | right colon in forward view |
Primary outcome
number of additional identified polyps with right colon scope retroflexion
Time frame: one week
2 secondary outcomes
Change in colorectal cancer (CRC) surveillance intervals among screening-surveillance patients
Time frame: one week
Rate of retroflexion-related adverse events.
Time frame: one week
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 20 Jul 2016.
- Background: PubMed 16454841van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
- Background: PubMed 21785352Vemulapalli KC, Rex DK. Evolving techniques in colonoscopy. Curr Opin Gastroenterol. 2011 Sep;27(5):430-8. doi: 10.1097/MOG.0b013e328349cfc0.
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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.
Konstantinos Triantafyllou, Prof study director
Hepatogastroenterology Unit, 2nd Department of Internal Medicine and Research Institute, Attikon University General Hospital, University of Athens, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing retroflexion and forward view in people with Colon Neoplasms, run by Attikon Hospital at 1 site in Greece.
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 6 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 20 Jul 2016. 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 Greece. 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 additional identified polyps with right colon scope retroflexion (time frame: one week). 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 NCT02838186, which also lists 2 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 20 Jul 2016.