Colorectal PolypsNCT00988676
The Effect of Bowel Preparation Status on the Polyp Missing Rate
An observational study of Colorectal Polyps and Colonoscopy, run by Konkuk University Hospital at 1 site in South Korea.
Trial summary
High quality bowel cleaning preparation was most important prerequisites of a accurate colonoscopy, because even a small amount of residual fecal matter can obscure small polyps and increase unnecessary procedure time. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Polyps, Colonoscopy, Bowel Preparation
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Mar 2010
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center
Who may be able to join
- The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center
Who cannot join
- Colonoscopy was not reached the caecum
- The patients with 10 or more polyps (who suspected polyposis syndrome)
- Bowel preparation was inadequate when 2nd stage colonoscopic polypectomy
- The patients with inflammatory bowel disease or suspected inflammatory bowel disease
- The patients had a history of bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Bowel Preparation Status on the Polyp Missing Rate During Colonoscopy: Prospective Study Using Tandem Colonoscopic Evaluation
High quality bowel cleaning preparation was most important prerequisites of a accurate colonoscopy, because even a small amount of residual fecal matter can obscure small polyps and increase unnecessary procedure time. Until now, several studies evaluated the impact of bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate in patients with adequate bowel preparation status to that in patients with inadequate bowel preparation status during colonoscopy. However, there was no direct measurement the effect bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem colonoscopic evaluation in prospective setting.
Read the detailed description
- Study flow
- All patients perform Colonoscopy
- record the polyp size, shape, location and number
- record the factors affecting polyp missing rate
- Patients' age / gender
- Indication of colonoscopy
- colonoscopist career
- colonoscopy withdrawal time
- bowel preparation status according to scale of U.S. Multi-Society Task Force on colorectal cancer, Aronchick's scale and Ottawa bowel preparation quality scale
- the patients needed or wanted to 2nd stage colonoscopic polypectomy (2nd stage polypectomy was performed within 6 month)
- record additionally detected polyp - size, shape, location and number
- Conditions
- Colorectal Polyps, Colonoscopy, Bowel Preparation, Polyp Missing Rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| colonoscopy | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Konkuk University Medical Center, Konkuk University
- Investigators
- Sung Noh Hong, M.D., Study director, Konkuk University Medical Center; Konkuk University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988676
- Sponsor's protocol ID
- KUH1010135
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2009
- Last updated
- 20 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bowel Preparation Status on the Polyp Missing Rate During Colonoscopy: Prospective Study Using Tandem Colonoscopic Evaluation
- ClinicalTrials.gov ID
- NCT00988676
- Acronym / sponsor ID
- KUH1010135
- Conditions
- Colorectal Polyps, Colonoscopy, Bowel Preparation, Polyp Missing Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Konkuk University HospitalUniversity, hospital or other
- Collaborators
- Konkuk University Medical Center, Konkuk University
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Oct 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.
High quality bowel cleaning preparation was most important prerequisites of a accurate colonoscopy, because even a small amount of residual fecal matter can obscure small polyps and increase unnecessary procedure time. Until now, several studies evaluated the impact of bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate in patients with adequate bowel preparation status to that in patients with inadequate bowel preparation status during colonoscopy. However, there was no direct measurement the effect bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem colonoscopic evaluation in prospective setting.
Detailed description
- Study flow
- All patients perform Colonoscopy
- record the polyp size, shape, location and number
- record the factors affecting polyp missing rate
- Patients' age / gender
- Indication of colonoscopy
- colonoscopist career
- colonoscopy withdrawal time
- bowel preparation status according to scale of U.S. Multi-Society Task Force on colorectal cancer, Aronchick's scale and Ottawa bowel preparation quality scale
- the patients needed or wanted to 2nd stage colonoscopic polypectomy (2nd stage polypectomy was performed within 6 month)
- record additionally detected polyp - size, shape, location and number
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| colonoscopy | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center
Key inclusion criteria (1 listed)
- The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center
Key exclusion criteria (5 listed)
- Colonoscopy was not reached the caecum
- The patients with 10 or more polyps (who suspected polyposis syndrome)
- Bowel preparation was inadequate when 2nd stage colonoscopic polypectomy
- The patients with inflammatory bowel disease or suspected inflammatory bowel disease
- The patients had a history of bowel resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Apr 2010.
Related trials for Colorectal Polyps
Recruiting
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Not yet recruiting
Social Software-Based Intelligent Management System for Bowel Preparation
Colorectal Polyp, Colorectal Adenoma
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.
Sung Noh Hong, M.D. study director
Konkuk University Medical Center; Konkuk University School of Medicine
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 Polyps and Colonoscopy, run by Konkuk University Hospital at 1 site in South Korea.
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 20 Apr 2010. 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 South Korea. 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.
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 Apr 2010.