ColonoscopyNCT00748293
Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet
A study testing Low-residue diet in people with Colonoscopy and Colon Cleansing, run by National Taiwan University Hospital at 5 sites in Taiwan.
Trial summary
Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to 2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation with 2000 ml PEG-ELS. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy, Colon Cleansing, Low-Reside Diet
- What is being tested?
- Low-residue diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 5 sitesTaiwan
- Study dates
- Sep 2008to Jan 2009
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who receives colonoscopy for screening or for clinical purpose
Who cannot join
- Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites, 5 recruiting
- Recruiting
E-DA Hospital
Kaohsiung City
Chi-Yang Chang, MD, chiyang1112@gmail.com
Chi-Yang Chang, MD
- Recruiting
Buddhist Tzu-Chi General Hospital
Taipei
Chien-Hwa Chen, MD
Chien-Hwa Chen, MD
- Recruiting
En Chu Kong Hospital
Taipei
Chang-Shyue Yang, MD
Chang-Shyue Yang, MD
- Recruiting
National Taiwan University Hospital
Taipei
Han-Mo Chiu, MD, 886-2-23123456 ext. 63354, hanmochiu@ntu.edu.tw
Han-Mo Chiu, MD
- Recruiting
Taipei Medical University Hospital
Taipei
Chun-Chao Chang, MD, chunchao@tmu.edu.tw
Chun-Chao Chang, MD
About this study
Official title: Achievement of Better Examinee Compliance on Colon Cleansing Before Colonoscopy Without Sacrificing Cleansing Effect - A Multi-Center Endoscopist-Blinded Randomized Trial Using Commercialized Low-Residue Diet
Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to 2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation with 2000 ml PEG-ELS. Poor patient compliance, however, is the main hurdle to complete ingestion of 2000 ml PEG-ELS not only for subjects with lower body weight but also for those with normal BMI or body weight.The main cause of poor patient compliance includes abdominal pain, bloating, nausea or vomiting during ingestion of cleansing fluid.Though diet restriction with low-fiber diet is always advised to every screen before colonoscopy, the extent of diet restriction is widely variable and thus influences the degree of colon cleansing.
With commercialized low-residue diet (CLRD), diet restriction will be well controlled and variability of colon cleansing can be minimized such that guarantee a colonoscopy with good quality. In this RCT, we will compare the compliance of screen during colon cleansing using different protocol: namely 2000 ml PEG-ELS vs. 1500 ml plus low-residue diet.
Read the detailed description
Setting: A multi-center study including the following teaching hospitals:
National Taiwan University Hospital, Taipei Taipei Medical University Hospital, Taipei E-Da Hospital, Kaohsiung Buddhist Tzu-Chi General Hospital, Taipei En Chu Kong Hospital, Taipei Far Eastern Memorial Hospital, Taipei
Study design: RCT, single blinded
Study subjects:
Inclusion criteria: Subjects who receives colonoscopy for screening or for clinical purpose Exclusion criteria: Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30
Grouping: subjects will be randomized to the following groups:
- Group A: 2000 ml PEG-ELS
- Group B: 1500ml PEG-ELS with CLRD Randomization process: Random block sheet
Measurements:
- Subjects who obey protocol or violate/withdraw protocol will be all recorded.
- Parameters concerning patient compliance
- Number of detected adenoma and their topographical distribution
- Time required for A. Cecal intubation B. Overall procedure time
- Colon cleansing effect evaluation
The degree of cleansing will be recorded individually for each bowel segment (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon). Each segment will be rated using a 5-point scale: 4, very good-colon empty and clean; 3, good-presence of clear liquid in the gut; 2, moderate-presence of brown liquid or small amounts of semisolid residual stool, fully removable by suction or displaceable, thus allowing a complete visualization of the underlying mucosa; 1, bad-presence of semisolid stool, only partially removable with a risk of incomplete underlying mucosal visualization; and 0, very bad-presence of semisolid or solid stool, colonoscopy incomplete or has to be stopped. The overall quality of colonic cleansing will be based on the assessment of the individual segments using a scale of A, all segments clean (i.e., scores of 3 or 4 in all segments); B, residual brown liquid or suctionable semisolid stool (i.e., a score of 2) in at least one segment; C, partially removable stool preventing complete visualization of mucosa (i.e., a score of 1) in at least one segment; or D, at least one segment can not be examined due to the presence of solid stool (i.e., a score of 0). A grade of either A or B was defined, a priori, as successful colon cleansing.
Sample size estimation:
Assuming 80% power and significance level at 0.05, totally at least 112 cases will be required for each group (assuming 90% cases in 2000 ml achieving good or excellent preparation and 76% of 1500mL plus low-residue diet achieving the same cleansing effect).
- Conditions
- Colonoscopy, Colon Cleansing, Low-Reside Diet
- Being tested
- Low-residue diet
- Keywords
- Colonoscopy, Colon cleansing, Low-reside diet, Compliance, PEG-ELS
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-residue dietOther
Commercialized (not yet marketed)low-residue diet
| Study group | Role | What they receive |
|---|---|---|
| A | No intervention | PEG-ELS 2000 ml ingestion in the morning of colonoscopy |
| B | Other | Low-reside diet on previous day (breakfast, lunch and dinner), PEG-ELS 1500 mL in the morning of colonoscopy Receives: Other: Low-residue diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colon cleansing level
Measured: At the timing of colonoscopy
Secondary outcomes (4)
adenoma detection rate
Measured: At the timing of colonoscopy
Cecal intubation time
Measured: At the timing of colonoscopy
Patient compliance including abdominal symptoms during colon cleansing, bowel movement on the way to hospital
Measured: -2hr
Whole procedural time
Measured: At the timing of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Medical University Hospital, E-DA Hospital, Buddhist Tzu Chi General Hospital, En Chu Kong Hospital
- Investigators
- Han-Mo Chiu, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748293
- Sponsor's protocol ID
- 200802030R
- Status last verified
- Sep 2008
- First submitted
- 5 Sep 2008
- Last updated
- 8 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achievement of Better Examinee Compliance on Colon Cleansing Before Colonoscopy Without Sacrificing Cleansing Effect - A Multi-Center Endoscopist-Blinded Randomized Trial Using Commercialized Low-Residue Diet
- ClinicalTrials.gov ID
- NCT00748293
- Acronym / sponsor ID
- 200802030R
- Conditions
- Colonoscopy, Colon Cleansing, Low-Reside Diet
- Keywords
- Colonoscopy, Colon cleansing, Low-reside diet, Compliance, PEG-ELS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taipei Medical University Hospital, E-DA Hospital, Buddhist Tzu Chi General Hospital, En Chu Kong Hospital
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 8 Sep 2008 (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.
Good colon cleansing is pivotal for achieving speedy and safe colonoscopic examination with high adenoma detection rate.Previous studies, including our previous RCT conducted in 2004 to 2005, have demonstrated that high yield rate can be achieved by on-the-day colon preparation with 2000 ml PEG-ELS. Poor patient compliance, however, is the main hurdle to complete ingestion of 2000 ml PEG-ELS not only for subjects with lower body weight but also for those with normal BMI or body weight.The main cause of poor patient compliance includes abdominal pain, bloating, nausea or vomiting during ingestion of cleansing fluid.Though diet restriction with low-fiber diet is always advised to every screen before colonoscopy, the extent of diet restriction is widely variable and thus influences the degree of colon cleansing.
With commercialized low-residue diet (CLRD), diet restriction will be well controlled and variability of colon cleansing can be minimized such that guarantee a colonoscopy with good quality. In this RCT, we will compare the compliance of screen during colon cleansing using different protocol: namely 2000 ml PEG-ELS vs. 1500 ml plus low-residue diet.
Detailed description
Setting: A multi-center study including the following teaching hospitals:
National Taiwan University Hospital, Taipei Taipei Medical University Hospital, Taipei E-Da Hospital, Kaohsiung Buddhist Tzu-Chi General Hospital, Taipei En Chu Kong Hospital, Taipei Far Eastern Memorial Hospital, Taipei
Study design: RCT, single blinded
Study subjects:
Inclusion criteria: Subjects who receives colonoscopy for screening or for clinical purpose Exclusion criteria: Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30
Grouping: subjects will be randomized to the following groups:
- Group A: 2000 ml PEG-ELS
- Group B: 1500ml PEG-ELS with CLRD Randomization process: Random block sheet
Measurements:
- Subjects who obey protocol or violate/withdraw protocol will be all recorded.
- Parameters concerning patient compliance
- Number of detected adenoma and their topographical distribution
- Time required for A. Cecal intubation B. Overall procedure time
- Colon cleansing effect evaluation
The degree of cleansing will be recorded individually for each bowel segment (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon). Each segment will be rated using a 5-point scale: 4, very good-colon empty and clean; 3, good-presence of clear liquid in the gut; 2, moderate-presence of brown liquid or small amounts of semisolid residual stool, fully removable by suction or displaceable, thus allowing a complete visualization of the underlying mucosa; 1, bad-presence of semisolid stool, only partially removable with a risk of incomplete underlying mucosal visualization; and 0, very bad-presence of semisolid or solid stool, colonoscopy incomplete or has to be stopped. The overall quality of colonic cleansing will be based on the assessment of the individual segments using a scale of A, all segments clean (i.e., scores of 3 or 4 in all segments); B, residual brown liquid or suctionable semisolid stool (i.e., a score of 2) in at least one segment; C, partially removable stool preventing complete visualization of mucosa (i.e., a score of 1) in at least one segment; or D, at least one segment can not be examined due to the presence of solid stool (i.e., a score of 0). A grade of either A or B was defined, a priori, as successful colon cleansing.
Sample size estimation:
Assuming 80% power and significance level at 0.05, totally at least 112 cases will be required for each group (assuming 90% cases in 2000 ml achieving good or excellent preparation and 76% of 1500mL plus low-residue diet achieving the same cleansing effect).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | No intervention | –PEG-ELS 2000 ml ingestion in the morning of colonoscopy |
| B | Other | Other: Low-residue dietLow-reside diet on previous day (breakfast, lunch and dinner), PEG-ELS 1500 mL in the morning of colonoscopy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who receives colonoscopy for screening or for clinical purpose
Key exclusion criteria (1 listed)
- Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30
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 |
|---|---|---|
| Low-residue dietCommercialized (not yet marketed)low-residue diet | Other | B |
Primary outcome
Colon cleansing level
Time frame: At the timing of colonoscopy
4 secondary outcomes
adenoma detection rate
Time frame: At the timing of colonoscopy
Cecal intubation time
Time frame: At the timing of colonoscopy
Patient compliance including abdominal symptoms during colon cleansing, bowel movement on the way to hospital
Time frame: -2hr
Whole procedural time
Time frame: At the timing of colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2008.
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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.
Han-Mo Chiu, MD principal investigator
National Taiwan University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-residue diet in people with Colonoscopy and Colon Cleansing, run by National Taiwan University Hospital at 5 sites in Taiwan.
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: status not confirmed, as of the sponsor's last update on 8 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Mo Chiu, MD (886-2-23123456 ext. 63354, hanmochiu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colon cleansing level (time frame: At the timing of colonoscopy). 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 Sep 2008; AzTrials last refreshed its copy on 7 Nov 2026.