Colonic NeoplasmsNCT01675934
Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
A study testing Retroflexion with the adult colonoscope. and Retroflexion with the pediatric colonoscope. in people with Colonic Neoplasms, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Retroflexion with the adult colonoscope. and Retroflexion with the pediatric colonoscope.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to May 2013
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients over the age 18 undergoing screening or surveillance colonoscopy
Who cannot join
- Age less than 18
- Pregnant
- History of ulcerative colitis or Crohn's disease
- History of polyposis syndromes
- History of colon resection
- Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Surgery Center
Milwaukee, Wisconsin, 53226
About this study
Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.
Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.
Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.
- Conditions
- Colonic Neoplasms
- Being tested
- Retroflexion with the adult colonoscope., Retroflexion with the pediatric colonoscope.
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroflexion with the adult colonoscope.Procedure or surgery
Retroflexion with the pediatric colonoscope.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adult colonoscope | Active comparator | Use of the adult colonoscope. Receives: Procedure: Retroflexion with the adult colonoscope. |
| Pediatric colonoscope | Active comparator | Use of the pediatric colonoscope. Receives: Procedure: Retroflexion with the pediatric colonoscope. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.
Measured: After 50% and 100% of patient enrollment is complete.
Secondary outcomes (2)
Adenoma detection rate in forward and retroflexed views.
Measured: After 50% and 100% of patient enrollment is complete.
Reasons for failure of retroflexion.
This will be assessed as a yes/no variable. In addition, the specific reasons that the endoscopist could not retroflex the colonoscope in the right colon will assessed, such as the colonoscope not being able to be advanced to the cecum, small diameter of the right colon, too much resistance encountered when attempting retroflexion that the endoscopist does not feel comfortable with, etc.
Measured: After 50% and 100% of patient enrollment is complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionMay 2013
Why it stopped: PI has left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Young Oh, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675934
- Sponsor's protocol ID
- PRO00017208
- Status last verified
- Jan 2016
- First submitted
- 28 Aug 2012
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes
- ClinicalTrials.gov ID
- NCT01675934
- Acronym / sponsor ID
- PRO00017208
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Aug 2012 (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.
Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.
Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.
Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult colonoscope | Active comparator | Procedure: Retroflexion with the adult colonoscope.Use of the adult colonoscope. |
| Pediatric colonoscope | Active comparator | Procedure: Retroflexion with the pediatric colonoscope.Use of the pediatric colonoscope. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients over the age 18 undergoing screening or surveillance colonoscopy
Key exclusion criteria (6 listed)
- Age less than 18
- Pregnant
- History of ulcerative colitis or Crohn's disease
- History of polyposis syndromes
- History of colon resection
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 |
|---|---|---|
| Retroflexion with the adult colonoscope. | Procedure or surgery | Adult colonoscope |
| Retroflexion with the pediatric colonoscope. | Procedure or surgery | Pediatric colonoscope |
Primary outcome
Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.
Time frame: After 50% and 100% of patient enrollment is complete.
2 secondary outcomes
Adenoma detection rate in forward and retroflexed views.
Time frame: After 50% and 100% of patient enrollment is complete.
Reasons for failure of retroflexion.
Time frame: After 50% and 100% of patient enrollment is complete.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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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.
Young Oh, MD principal investigator
Medical College of Wisconsin
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 with the adult colonoscope. and Retroflexion with the pediatric colonoscope. in people with Colonic Neoplasms, run by Medical College of Wisconsin at 1 site 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 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: withdrawn, as of the sponsor's last update on 8 Jan 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes. (time frame: After 50% and 100% of patient enrollment is complete.). 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 8 Jan 2016.