Colorectal CancerNCT01035775
Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
A study testing Inspection during insertion and Inspection during withdrawal in people with Colorectal Cancer and Colorectal Polyps, run by Indiana University at 2 sites in United States.
Trial summary
Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Polyps
- What is being tested?
- Inspection during insertion and Inspection during withdrawal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Jan 2011
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- Patients undergoing colonoscopy for screening or surveillance indications
Who cannot join
- Previous surgical resection of all or part of the colon.
- Inability to give informed consent.
- Ulcerative colitis or Crohn's disease.
- Polyposis syndrome or Lynch syndrome (HNPCC)
- Any comorbid condition which the investigator deems would put the patient at increased risk from a slightly prolonged procedure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Hospital
Indianapolis, Indiana, 46202
Beltway Surgery Center
Indianapolis, Indiana, 46280
About this study
Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Read the detailed description
Background: Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Thus, colonoscopy is typically performed by rapidly passing the instrument through the loops and bends of the colon in order to reach the tip of the cecum, and then performing a slow withdrawal in which the tip of the instrument is systematically deflected, and the mucosa is careful cleaned and suctioned, to expose all of the colonic mucosa for viewing.
Many experienced colonoscopists recognize that small polyps seen incidentally but not removed during insertion are sometimes quite difficult to find during withdrawal. The reason for this observation is probably because the colon is in a very different anatomical conformation during endoscope insertion and withdrawal. During insertion, the colon is in its natural conformation in which the sigmoid and transverse colon has several sharp bends or flexures, and the overall length has not yet been shortened. In this phase, the colon is often significantly stretched because of the formation of loops and bends in the colonoscope. This greatly affects the conformation of the colonic wall visualized proximal to the instrument tip. During withdrawal, the colon is shortened and pleated over the colonoscope, with successive regions of the colon being inspected as they slip off the end of the instrument. Thus, segments of visualized colon are often much straighter during withdrawal than during insertion. The insertion and withdrawal phases, therefore, expose somewhat different sections of the mucosal surface to the colonoscope and inspection on insertion and withdrawal are, quite possibly, complementary.
Aims: This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Study procedure: In this study, we plan to investigate whether a specified interval of inspection during insertion can increase overall adenoma detection. We will conduct a randomized controlled trial, in which patients will be randomized to have all of the inspection performed during the withdrawal phase (as is usual care) versus having several minutes of examination specifically devoted to inspection during insertion.
- Conditions
- Colorectal Cancer, Colorectal Polyps
- Being tested
- Inspection during insertion, Inspection during withdrawal
- Keywords
- Colonoscopy, Adenoma detection, Colorectal polyps
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspection during insertionProcedure or surgery
The colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument.
Inspection during withdrawalProcedure or surgery
The colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum. The instrument will be inserted to the cecum without deliberate inspection.
| Study group | Role | What they receive |
|---|---|---|
| Insertion | Experimental | Inspection on colonoscope insertion in addition to inspection during withdrawal from the cecum. Receives: Procedure: Inspection during insertion |
| Withdrawal | Active comparator | Inspection during withdrawal (usual care) without deliberate inspection during insertion. Receives: Procedure: Inspection during withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: During colonoscopy
Secondary outcomes (3)
Sedation dose
Measured: During colonoscopy
Post procedural pain scores
Measured: Within 1 hour of colonoscopy
Proportion of patients with at least one adenoma detected
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionJan 2011
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas K. Rex, Indiana University
- Investigators
- Douglas K Rex, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01035775
- Sponsor's protocol ID
- 0909-22
- Status last verified
- Nov 2018
- First submitted
- 18 Dec 2009
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hewett DG, Rex DK. Inspection on instrument insertion during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2012 Aug;76(2):381-7. doi: 10.1016/j.gie.2012.04.454.
PubMed 22817789
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inspection During Insertion Improve Adenoma Yields During Colonoscopy?
- ClinicalTrials.gov ID
- NCT01035775
- Acronym / sponsor ID
- 0909-22
- Conditions
- Colorectal Cancer, Colorectal Polyps
- Keywords
- Colonoscopy, Adenoma detection, Colorectal polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Dec 2009 (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 is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Detailed description
Background: Colonoscopy is not a perfect test. It misses a substantial number of neoplastic lesions and has some risk of missing cancer. Nearly all work on detection during colonoscopy has focused on the withdrawal phase of the examination. Thus, colonoscopy is typically performed by rapidly passing the instrument through the loops and bends of the colon in order to reach the tip of the cecum, and then performing a slow withdrawal in which the tip of the instrument is systematically deflected, and the mucosa is careful cleaned and suctioned, to expose all of the colonic mucosa for viewing.
Many experienced colonoscopists recognize that small polyps seen incidentally but not removed during insertion are sometimes quite difficult to find during withdrawal. The reason for this observation is probably because the colon is in a very different anatomical conformation during endoscope insertion and withdrawal. During insertion, the colon is in its natural conformation in which the sigmoid and transverse colon has several sharp bends or flexures, and the overall length has not yet been shortened. In this phase, the colon is often significantly stretched because of the formation of loops and bends in the colonoscope. This greatly affects the conformation of the colonic wall visualized proximal to the instrument tip. During withdrawal, the colon is shortened and pleated over the colonoscope, with successive regions of the colon being inspected as they slip off the end of the instrument. Thus, segments of visualized colon are often much straighter during withdrawal than during insertion. The insertion and withdrawal phases, therefore, expose somewhat different sections of the mucosal surface to the colonoscope and inspection on insertion and withdrawal are, quite possibly, complementary.
Aims: This randomized, controlled trial will compare the additional effect on the rate of adenoma detection of mucosal inspection during colonoscope insertion, with inspection during instrument withdrawal, in patients undergoing colonoscopy for colorectal cancer screening or surveillance.
Study procedure: In this study, we plan to investigate whether a specified interval of inspection during insertion can increase overall adenoma detection. We will conduct a randomized controlled trial, in which patients will be randomized to have all of the inspection performed during the withdrawal phase (as is usual care) versus having several minutes of examination specifically devoted to inspection during insertion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insertion | Experimental | Procedure: Inspection during insertionInspection on colonoscope insertion in addition to inspection during withdrawal from the cecum. |
| Withdrawal | Active comparator | Procedure: Inspection during withdrawalInspection during withdrawal (usual care) without deliberate inspection during insertion. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 years
- Patients undergoing colonoscopy for screening or surveillance indications
Key exclusion criteria (5 listed)
- Previous surgical resection of all or part of the colon.
- Inability to give informed consent.
- Ulcerative colitis or Crohn's disease.
- Polyposis syndrome or Lynch syndrome (HNPCC)
- Any comorbid condition which the investigator deems would put the patient at increased risk from a slightly prolonged procedure
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 |
|---|---|---|
| Inspection during insertionThe colonic mucosa will be inspected for lesions during insertion of the instrument, and during withdrawal of the instrument. | Procedure or surgery | Insertion |
| Inspection during withdrawalThe colonic mucosa will be inspected for lesions only during withdrawal of the instrument from the cecum. The instrument will be inserted to the cecum without deliberate inspection. | Procedure or surgery | Withdrawal |
Primary outcome
Adenoma detection rate
Time frame: During colonoscopy
3 secondary outcomes
Sedation dose
Time frame: During colonoscopy
Post procedural pain scores
Time frame: Within 1 hour of colonoscopy
Proportion of patients with at least one adenoma detected
Time frame: During 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 16 Nov 2018.
- Derived from this study: PubMed 22817789Hewett DG, Rex DK. Inspection on instrument insertion during colonoscopy: a randomized controlled trial. Gastrointest Endosc. 2012 Aug;76(2):381-7. doi: 10.1016/j.gie.2012.04.454.
- 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.
Douglas K Rex, M.D. principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspection during insertion and Inspection during withdrawal in people with Colorectal Cancer and Colorectal Polyps, run by Indiana University at 2 sites in United States.
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 2 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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: During colonoscopy). 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 NCT01035775, 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 16 Nov 2018.