Colon AdenomaNCT03619122
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate
A study testing Second Examination in people with Colon Adenoma, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Adenoma
- What is being tested?
- Second Examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Jun 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients undergoing colonoscopy for screening in our hospital
Who cannot join
- previous history of resection of colon;
- familial polyposis syndrome
- inflammatory bowel disease
- active antiplatelet or anticoagulant therapy prevent polypectomy;
- pregnancy or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Second Forward View Examination of Proximal Colon on Adenoma Detection Rate: A Randomized Clinical Trial
This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.
- Conditions
- Colon Adenoma
- Being tested
- Second Examination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second ExaminationProcedure or surgery
The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.
| Study group | Role | What they receive |
|---|---|---|
| Second Examination | Experimental | Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination. Receives: Procedure: Second Examination |
| Traditional Examinaiton | No intervention | Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is withdrawn to the anus directly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
per-patient detection rate of adenoma of proximal colon
the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start1 Sep 2018
- Primary completion31 May 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619122
- Sponsor's protocol ID
- 2018-R014
- Status last verified
- Jul 2019
- First submitted
- 2 Aug 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shan K, Lu H, Zhang Z, Xie J, Xu L, Wang W, Hu C, Xu L. Impact of second forward-view examination on adenoma detection rate during unsedated colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2021 May 10;21(1):213. doi: 10.1186/s12876-021-01783-9.
PubMed 33971824
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Second Forward View Examination of Proximal Colon on Adenoma Detection Rate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03619122
- Acronym / sponsor ID
- 2018-R014
- Conditions
- Colon Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 7 Aug 2018 (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.
This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second Examination | Experimental | Procedure: Second ExaminationEligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination. |
| Traditional Examinaiton | No intervention | –Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is withdrawn to the anus directly. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients undergoing colonoscopy for screening in our hospital
Key exclusion criteria (5 listed)
- previous history of resection of colon;
- familial polyposis syndrome
- inflammatory bowel disease
- active antiplatelet or anticoagulant therapy prevent polypectomy;
- pregnancy or lactating 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 |
|---|---|---|
| Second ExaminationThe colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination. | Procedure or surgery | Second Examination |
Primary outcome
per-patient detection rate of adenoma of proximal colon
Time frame: 1 day
the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy
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 12 Jul 2019.
- Derived from this study: PubMed 33971824Shan K, Lu H, Zhang Z, Xie J, Xu L, Wang W, Hu C, Xu L. Impact of second forward-view examination on adenoma detection rate during unsedated colonoscopy: a randomized controlled trial. BMC Gastroenterol. 2021 May 10;21(1):213. doi: 10.1186/s12876-021-01783-9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second Examination in people with Colon Adenoma, run by Ningbo No. 1 Hospital at 1 site 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 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 12 Jul 2019. 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 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?
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?
per-patient detection rate of adenoma of proximal colon (time frame: 1 day). 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 NCT03619122, which also lists 1 linked publication.
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 12 Jul 2019.