Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Taiwan University Hospital Taipei Medical University Hospital E-DA Hospital Buddhist Tzu Chi General Hospital En Chu Kong Hospital |
---|---|
Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00748293 |
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.
Condition | Intervention |
---|---|
Colonoscopy Colon Cleansing Low-Reside Diet |
Other: Low-residue diet |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy 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 |
Estimated Enrollment: | 224 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: No Intervention
PEG-ELS 2000 ml ingestion in the morning of colonoscopy
|
|
B
Low-reside diet on previous day (breakfast, lunch and dinner), PEG-ELS 1500 mL in the morning of colonoscopy
|
Other: Low-residue diet
Commercialized (not yet marketed)low-residue diet
|
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:
Measurements:
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).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Han-Mo Chiu, MD | 886-2-23123456 ext 63354 | hanmochiu@ntu.edu.tw |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Han-Mo Chiu, MD 886-2-23123456 ext 63354 hanmochiu@ntu.edu.tw | |
Principal Investigator: Han-Mo Chiu, MD | |
E-DA Hospital | Recruiting |
Kaohsiung, Taiwan | |
Contact: Chi-Yang Chang, MD chiyang1112@gmail.com | |
Principal Investigator: Chi-Yang Chang, MD | |
Buddhist Tzu-Chi General Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Chien-Hwa Chen, MD | |
Principal Investigator: Chien-Hwa Chen, MD | |
En Chu Kong Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Chang-Shyue Yang, MD | |
Principal Investigator: Chang-Shyue Yang, MD | |
Taipei Medical University Hospital | Recruiting |
Taipei, Taiwan | |
Contact: Chun-Chao Chang, MD chunchao@tmu.edu.tw | |
Principal Investigator: Chun-Chao Chang, MD |
Principal Investigator: | Han-Mo Chiu, MD | National Taiwan University Hospital |
Responsible Party: | National Taiwan Univesity Hospital ( Han-Mo Chiu ) |
Study ID Numbers: | 200802030R |
Study First Received: | September 5, 2008 |
Last Updated: | September 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00748293 History of Changes |
Health Authority: | Taiwan: Department of Health |
Colonoscopy Colon cleansing Low-reside diet Compliance PEG-ELS |