ColoRectal CancerNCT02985944
Withdrawal Time and Use of Wide-angle Endoscope to Increase the Adenoma Detection Rate of Screening Colonoscopy
An observational study of ColoRectal Cancer and Colon Polyp, run by ASST Rhodense at 1 site in Italy.
Trial summary
Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy withdrawal time >6min has been suggested to increase the ADR since it allows for thorough evaluation of the several hidden areas of the colon. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ColoRectal Cancer, Colon Polyp
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2016to Dec 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult outpatients undergoing colonoscopy for different indications
Who may be able to join
- Indication for colonoscopy, age 18-85
Who cannot join
- Previous abdominal colon resection, colon obstruction, inadequate preparation and incomplete examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Longer Withdrawal Time or of the Use of a Wide-angle Endoscope on the Adenoma Detection Rate of Screening Colonoscopy
Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy withdrawal time >6min has been suggested to increase the ADR since it allows for thorough evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle view. In the present study the authors evaluate the impact of WT on ADR for High Definition Standard Endoscopes with just a single imager to the FUSE endoscope.
Read the detailed description
Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An endoscopy withdrawal time >6min has been suggested to increase the adenoma detection rate since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide angle view.
Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a FUSE endoscope or of interventions directed at optimizing withdrawal time.
to assess the impact of different factors in influencing the withdrawal time
Methods A prospective non-randomized observational single-center study involving consecutive outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous abdominal colon resection, obstruction, inadequate preparation and incomplete examination were exclusion criteria.
In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy withdrawal times will be measured without the endoscopists' knowledge of being monitored.
During a subsequent 3-month period the same endoscopists will perform further 500 colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a minimum 6-minute withdrawal time. In this second phase withdrawal times will be again measured, but endoscopists will be aware of being monitored.
The following parameters will be recorded:
- Demographic and general characteristics
- Indications to colonoscopy
- Colonoscopy findings
- Quality of preparation: Boston scale
- Time to reach the coecum
- Withdrawal time The adenoma detection rate and the mean adenomas per patients will be calculated.
- Conditions
- ColoRectal Cancer, Colon Polyp
- Being tested
- Colonoscopy
- Keywords
- colorectal cancer, Colon polyp, Colonoscopy, Adenoma detection rate
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Colonoscopy performed in adult consecutive patients for different indications
| Study group | Role | What they receive |
|---|---|---|
| Standard scope-short time | Standard colonoscopy with unmonitored withdrawal time Receives: Procedure: Colonoscopy | |
| FUSE scope-short time | Wide-angle colonoscopy with unmonitored withdrawal time Receives: Procedure: Colonoscopy | |
| Standard scope-long time | Standard colonoscopy with monitored withdrawal time Receives: Procedure: Colonoscopy | |
| FUSE scope-long time | Wide-angle colonoscopy with monitored withdrawal time Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
The rate of patient with at least one adenoma detected at colonoscopy
Measured: Up to 10 days from the end of endoscopy
Secondary outcomes (1)
Factors affecting the withdrawal time
Analysis of the factors (quality of preparation, indications for colonoscopy) likely to influence the withdrawal time
Measured: Up to 10 days from the end of endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColoRectal CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASST Rhodense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gianpiero manes, ASST Rhodense
- Investigators
- gianpiero manes, MD, Principal investigator, ASST Rhodense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985944
- Sponsor's protocol ID
- W-time
- Status last verified
- Jan 2021
- First submitted
- 27 Nov 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Longer Withdrawal Time or of the Use of a Wide-angle Endoscope on the Adenoma Detection Rate of Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT02985944
- Acronym / sponsor ID
- W-time
- Conditions
- ColoRectal Cancer, Colon Polyp
- Keywords
- colorectal cancer, Colon polyp, Colonoscopy, Adenoma detection rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- ASST RhodenseUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 7 Dec 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.
Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy withdrawal time >6min has been suggested to increase the ADR since it allows for thorough evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle view. In the present study the authors evaluate the impact of WT on ADR for High Definition Standard Endoscopes with just a single imager to the FUSE endoscope.
Detailed description
Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An endoscopy withdrawal time >6min has been suggested to increase the adenoma detection rate since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide angle view.
Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a FUSE endoscope or of interventions directed at optimizing withdrawal time.
to assess the impact of different factors in influencing the withdrawal time
Methods A prospective non-randomized observational single-center study involving consecutive outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous abdominal colon resection, obstruction, inadequate preparation and incomplete examination were exclusion criteria.
In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy withdrawal times will be measured without the endoscopists' knowledge of being monitored.
During a subsequent 3-month period the same endoscopists will perform further 500 colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a minimum 6-minute withdrawal time. In this second phase withdrawal times will be again measured, but endoscopists will be aware of being monitored.
The following parameters will be recorded:
- Demographic and general characteristics
- Indications to colonoscopy
- Colonoscopy findings
- Quality of preparation: Boston scale
- Time to reach the coecum
- Withdrawal time The adenoma detection rate and the mean adenomas per patients will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard scope-short time | – | Procedure: ColonoscopyStandard colonoscopy with unmonitored withdrawal time |
| FUSE scope-short time | – | Procedure: ColonoscopyWide-angle colonoscopy with unmonitored withdrawal time |
| Standard scope-long time | – | Procedure: ColonoscopyStandard colonoscopy with monitored withdrawal time |
| FUSE scope-long time | – | Procedure: ColonoscopyWide-angle colonoscopy with monitored withdrawal time |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult outpatients undergoing colonoscopy for different indications
Key inclusion criteria (1 listed)
- Indication for colonoscopy, age 18-85
Key exclusion criteria (1 listed)
- Previous abdominal colon resection, colon obstruction, inadequate preparation and incomplete examination
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 |
|---|---|---|
| ColonoscopyColonoscopy performed in adult consecutive patients for different indications | Procedure or surgery | FUSE scope-long time, FUSE scope-short time, Standard scope-long time, Standard scope-short time |
Primary outcome
Adenoma detection rate
Time frame: Up to 10 days from the end of endoscopy
The rate of patient with at least one adenoma detected at colonoscopy
1 secondary outcome
Factors affecting the withdrawal time
Time frame: Up to 10 days from the end of endoscopy
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 Jan 2021.
- Individual participant dataSharing planned: No
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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.
gianpiero manes, MD principal investigator
ASST Rhodense
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 ColoRectal Cancer and Colon Polyp, run by ASST Rhodense at 1 site 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 1 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 Jan 2021. 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 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: Up to 10 days from the end of endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2021.