Colorectal CancerNCT02139475
Factors Influencing Quality of Bowel Cleansing for Colonoscopy in Patients With Colorectal Cancer Surgery; Prospective Observational Study
An observational study of Colorectal Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 273 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Feb 2017
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing colonoscopy after colorectal cancer surgery
Who may be able to join
- age ≥ 20
- patients who underwent colorectal cancer surgery
- patients who underwent follow-up colonoscopy as a conventional medical procedures
Who cannot join
- age < 20
- patients who have ileus or bowel obstruction
- patients in pregnant status
- Patients who did not consent to research
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Through this, ultimately in patients with a history of colorectal cancer who have high risk of colorectal cancer, it could be possible to detect cancerous lesions early and increase the survival rate.
This study is based on observational study Subjects are the patients with colorectal cancer surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical records on the basis of information collected at the point of the colonoscopy performed Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient compliance and satisfaction are measured.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopy
- Keywords
- bowel cleansing, colorectal cancer surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy | patients undergoing colonoscopy after colorectal cancer surgery Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston bowel preparation scale (BBPS)
In this scale, the colon is divided in three segments: the right side (including cecum and ascending colon), the transverse colon (including the flexures) and the left sided colon, which includes the descending colon, sigmoid and rectum. Mucosal view should be scored after cleansing maneuvers like suctioning or washing have been performed. For all three sections cleansing is assessed and given a score ranging from 0 to 3. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. BBPS score ≥6 in considered an adequate bowel preparation.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: All the patients who had been targeted were registered.
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.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139475
- Sponsor's protocol ID
- 4-2013-0772
- Status last verified
- Dec 2017
- First submitted
- 13 May 2014
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Quality of Bowel Cleansing for Colonoscopy in Patients With Colorectal Cancer Surgery; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02139475
- Acronym / sponsor ID
- 4-2013-0772
- Conditions
- Colorectal Cancer
- Keywords
- bowel cleansing, colorectal cancer surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: All the patients who had been targeted were registered.
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 15 May 2014 (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.
The aim of this study is to clarify the factors influencing quality of bowel cleansing for colonoscopy in patients with colorectal cancer surgery and confirm the adequate bowel cleaning method for patients with colorectal cancer surgery. Through this, ultimately in patients with a history of colorectal cancer who have high risk of colorectal cancer, it could be possible to detect cancerous lesions early and increase the survival rate.
This study is based on observational study Subjects are the patients with colorectal cancer surgery who visits the out patients clinic for follow-up colonoscopy The patient's medical records on the basis of information collected at the point of the colonoscopy performed Quality of bowel cleansing is calculated with the Boston bowel preparation scale Patient compliance and satisfaction are measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy | – | Procedure: Colonoscopypatients undergoing colonoscopy after colorectal cancer surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing colonoscopy after colorectal cancer surgery
Key inclusion criteria (3 listed)
- age ≥ 20
- patients who underwent colorectal cancer surgery
- patients who underwent follow-up colonoscopy as a conventional medical procedures
Key exclusion criteria (4 listed)
- age < 20
- patients who have ileus or bowel obstruction
- patients in pregnant status
- Patients who did not consent to research
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 |
|---|---|---|
| Colonoscopy | Procedure or surgery | Colonoscopy |
Primary outcome
Boston bowel preparation scale (BBPS)
Time frame: 1 hour
In this scale, the colon is divided in three segments: the right side (including cecum and ascending colon), the transverse colon (including the flexures) and the left sided colon, which includes the descending colon, sigmoid and rectum. Mucosal view should be scored after cleansing maneuvers like suctioning or washing have been performed. For all three sections cleansing is assessed and given a score ranging from 0 to 3. Therefore, the maximum BBPS score for a perfectly clean colon without any residual liquid is 9 and the minimum BBPS score for an unprepared colon is 0. BBPS score ≥6 in considered an adequate bowel preparation.
Results and safety
The study was stopped early (reason given: All the patients who had been targeted were registered.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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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?
An observational study of Colorectal Cancer, run by Yonsei University 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Mar 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 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 was stopped early (reason given: All the patients who had been targeted were registered.). Results are not available in the source record.
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?
Boston bowel preparation scale (BBPS) (time frame: 1 hour). 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 29 Mar 2019.