Achievement of Better Examinee Compliance on Colon Cleansing Using Commercialized Low-Residue Diet

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
First received: September 5, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Colon cleansing level [ Time Frame: At the timing of colonoscopy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adenoma detection rate [ Time Frame: At the timing of colonoscopy ] [ Designated as safety issue: Yes ]
  • Cecal intubation time [ Time Frame: At the timing of colonoscopy ] [ Designated as safety issue: No ]
  • Patient compliance including abdominal symptoms during colon cleansing, bowel movement on the way to hospital [ Time Frame: -2hr ] [ Designated as safety issue: No ]
  • Whole procedural time [ Time Frame: At the timing of colonoscopy ] [ Designated as safety issue: No ]

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
No Intervention: A
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
Other Name: 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:

  1. Group A: 2000 ml PEG-ELS
  2. Group B: 1500ml PEG-ELS with CLRD Randomization process: Random block sheet

Measurements:

  1. Subjects who obey protocol or violate/withdraw protocol will be all recorded.
  2. Parameters concerning patient compliance
  3. Number of detected adenoma and their topographical distribution
  4. Time required for A. Cecal intubation B. Overall procedure time
  5. 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748293

Contacts
Contact: Han-Mo Chiu, MD 886-2-23123456 ext 63354 hanmochiu@ntu.edu.tw

Locations
Taiwan
E-DA Hospital Recruiting
Kaohsiung, Taiwan
Contact: Chi-Yang Chang, MD       chiyang1112@gmail.com   
Principal Investigator: Chi-Yang Chang, MD         
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         
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         
Sponsors and Collaborators
National Taiwan University Hospital
Taipei Medical University Hospital
E-DA Hospital
Buddhist Tzu Chi General Hospital
En Chu Kong Hospital
Investigators
Principal Investigator: Han-Mo Chiu, MD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Han-Mo Chiu, National Taiwan Univesity Hospital
ClinicalTrials.gov Identifier: NCT00748293     History of Changes
Other Study ID Numbers: 200802030R
Study First Received: September 5, 2008
Last Updated: September 5, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Colonoscopy
Colon cleansing
Low-reside diet
Compliance
PEG-ELS

ClinicalTrials.gov processed this record on April 20, 2014