Colorectal AdenomaSINOCOLO2017NCT03355443
Examining Techniques on Adenoma Miss Rate in Proximal Colon
A study testing Retroflexion and Re-examination in people with Colorectal Adenoma and Colorectal Polyp, run by Changhai Hospital at 3 sites in China.
Trial summary
The primary aim of this study is to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon. Other aims include to explore the data below when re-examination or retroflexion is used. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Polyp
- What is being tested?
- Retroflexion and Re-examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2017to Dec 2019
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result
Who cannot join
- Pregnant female patients
- Patients received colonoscopy in the past 5 years
- Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
- Patients who had previous abdominal surgery
- Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
- Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
- Patients who have inadequate bowel preparation
- Patients who reject to participate in this study
Trial locations and contacts
3 sites in 1 country.
Zi-Ye ZHAO, MD contact
China3 sites
the Sixth affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Chu-Jun LI, MBBS, 8602038777676
Zhongshan Hospital affiliated to Fudan University
Shanghai, 200032
Ping-Hong ZHOU, MD
Tianjin Renmin Hospital
Tianjin, 300121
Wen LI
About this study
Official title: Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy
The primary aim of this study is
- to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.
Other aims include to explore the data below when re-examination or retroflexion is used.
- Adenoma detection rate, ADR
- Polyp miss rate, PMR
- Polyp detection rate, PDR
- Withdrawal time, WT
Read the detailed description
AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)
- Conditions
- Colorectal Adenoma, Colorectal Polyp
- Being tested
- Retroflexion, Re-examination
- Keywords
- Colonoscopy, Lower Gastrointestinal Tract, Re-examination, Retroflexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RetroflexionProcedure or surgery
Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.
Re-examinationProcedure or surgery
Re-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion.
| Study group | Role | What they receive |
|---|---|---|
| Re-examination Group | Active comparator | Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method. Receives: Procedure: Re-examination |
| Retroflexion Group | Experimental | Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method. Receives: Procedure: Retroflexion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma miss rate in the proximal colon (AMR)
AMR refers to the rate of adenoma missing, calculated as the proportion of adenomas which are missing in the first examination. AMR in the proximal colon is calculated with only the proximal colon concerned.
Measured: At the end of the procedure, up to 1 hour
Secondary outcomes (1)
Adenoma Detection Rate in the proximal colon (ADR)
ADR refers to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. ADR in the proximal colon is calculated with only the proximal colon concerned.
Measured: At the end of the procedure, up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, En-Da Yu, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355443
- Sponsor's protocol ID
- SINOCOLO2017
- Other IDs
- 2017YFC1308802
- Acronym
- SINOCOLO2017
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kushnir VM, Oh YS, Hollander T, Chen CH, Sayuk GS, Davidson N, Mullady D, Murad FM, Sharabash NM, Ruettgers E, Dassopoulos T, Easler JJ, Gyawali CP, Edmundowicz SA, Early DS. Impact of retroflexion vs. second forward view examination of the right colon on adenoma detection: a comparison study. Am J Gastroenterol. 2015 Mar;110(3):415-22. doi: 10.1038/ajg.2015.21. Epub 2015 Mar 3.
PubMed 25732415Lee HS, Jeon SW, Park HY, Yeo SJ. Improved detection of right colon adenomas with additional retroflexion following two forward-view examinations: a prospective study. Endoscopy. 2017 Apr;49(4):334-341. doi: 10.1055/s-0042-119401. Epub 2016 Dec 8.
PubMed 27931050Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
PubMed 21679946Wang CL, Zhao ZY, Wu JY, Yan FH, Yuan J, Xing JJ, Wang H, Yu ED. Efficacy of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy: A prospective, randomized, pilot trial. Medicine (Baltimore). 2023 Aug 25;102(34):e34806. doi: 10.1097/MD.0000000000034806.
PubMed 37653767
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy
- ClinicalTrials.gov ID
- NCT03355443
- Acronym / sponsor ID
- SINOCOLO2017 / SINOCOLO2017
- Conditions
- Colorectal Adenoma, Colorectal Polyp
- Keywords
- Colonoscopy, Lower Gastrointestinal Tract, Re-examination, Retroflexion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Nov 2017 (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.
The primary aim of this study is
- to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.
Other aims include to explore the data below when re-examination or retroflexion is used.
- Adenoma detection rate, ADR
- Polyp miss rate, PMR
- Polyp detection rate, PDR
- Withdrawal time, WT
Detailed description
AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-examination Group | Active comparator | Procedure: Re-examinationRoutine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method. |
| Retroflexion Group | Experimental | Procedure: RetroflexionRoutine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result
Key exclusion criteria (8 listed)
- Pregnant female patients
- Patients received colonoscopy in the past 5 years
- Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
- Patients who had previous abdominal surgery
- Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
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 |
|---|---|---|
| RetroflexionRetroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum. | Procedure or surgery | Retroflexion Group |
| Re-examinationRe-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion. | Procedure or surgery | Re-examination Group |
Primary outcome
Adenoma miss rate in the proximal colon (AMR)
Time frame: At the end of the procedure, up to 1 hour
AMR refers to the rate of adenoma missing, calculated as the proportion of adenomas which are missing in the first examination. AMR in the proximal colon is calculated with only the proximal colon concerned.
1 secondary outcome
Adenoma Detection Rate in the proximal colon (ADR)
Time frame: At the end of the procedure, up to 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Results publication: PubMed 25732415Kushnir VM, Oh YS, Hollander T, Chen CH, Sayuk GS, Davidson N, Mullady D, Murad FM, Sharabash NM, Ruettgers E, Dassopoulos T, Easler JJ, Gyawali CP, Edmundowicz SA, Early DS. Impact of retroflexion vs. second forward view examination of the right colon on adenoma detection: a comparison study. Am J Gastroenterol. 2015 Mar;110(3):415-22. doi: 10.1038/ajg.2015.21. Epub 2015 Mar 3.
- Results publication: PubMed 27931050Lee HS, Jeon SW, Park HY, Yeo SJ. Improved detection of right colon adenomas with additional retroflexion following two forward-view examinations: a prospective study. Endoscopy. 2017 Apr;49(4):334-341. doi: 10.1055/s-0042-119401. Epub 2016 Dec 8.
- Results publication: PubMed 21679946Hewett DG, Rex DK. Miss rate of right-sided colon examination during colonoscopy defined by retroflexion: an observational study. Gastrointest Endosc. 2011 Aug;74(2):246-52. doi: 10.1016/j.gie.2011.04.005. Epub 2011 Jun 15.
- Derived from this study: PubMed 37653767Wang CL, Zhao ZY, Wu JY, Yan FH, Yuan J, Xing JJ, Wang H, Yu ED. Efficacy of cecal retroflexion observed on adenoma missing of ascending colon during colonoscopy: A prospective, randomized, pilot trial. Medicine (Baltimore). 2023 Aug 25;102(34):e34806. doi: 10.1097/MD.0000000000034806.
Related trials for Colorectal Adenoma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Active, not recruitingObservational study
Cholecystectomy, Biliary Diseases, and Colorectal Adenoma Risk: A Real-World Retrospective Study
Colorectal Adenoma, Cholecystectomy
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
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.
Zi-Ye ZHAO, MD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retroflexion and Re-examination in people with Colorectal Adenoma and Colorectal Polyp, run by Changhai Hospital at 3 sites in China.
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 8 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: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact En-Da YU, MBBS (08618699629177, endayu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma miss rate in the proximal colon (AMR) (time frame: At the end of the procedure, up to 1 hour). 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 NCT03355443, which also lists 4 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 28 Nov 2017.