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

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.

Study Overview

• Status: Unknown
• Conditions: Colonoscopy; Colon Cleansing; Low-Reside Diet
• Intervention / Treatment: Other: 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).

• Study Type: Interventional
• Enrollment (Anticipated): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan
    • Recruiting
    • E-DA hospital
    • Principal Investigator: Chi-Yang Chang, MD
    • Contact: Chi-Yang Chang, MD; Email: chiyang1112@gmail.com
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Chun-Chao Chang, MD; Email: chunchao@tmu.edu.tw
    • Principal Investigator: Chun-Chao Chang, MD
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Han-Mo Chiu, MD; Phone Number: 63354 886-2-23123456; Email: hanmochiu@ntu.edu.tw
    • Principal Investigator: Han-Mo Chiu, MD
  • Taipei, Taiwan
    • Recruiting
    • Buddhist Tzu-Chi General Hospital
    • Contact: Chien-Hwa Chen, MD
    • Principal Investigator: Chien-Hwa Chen, MD
  • Taipei, Taiwan
    • Recruiting
    • En Chu Kong Hospital
    • Contact: Chang-Shyue Yang, MD
    • Principal Investigator: Chang-Shyue Yang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: A; PEG-ELS 2000 ml ingestion in the morning of colonoscopy
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colon cleansing level	At the timing of colonoscopy

Secondary Outcome Measures

Outcome Measure	Time Frame
adenoma detection rate	At the timing of colonoscopy
Cecal intubation time	At the timing of colonoscopy
Patient compliance including abdominal symptoms during colon cleansing, bowel movement on the way to hospital	-2hr
Whole procedural time	At the timing of colonoscopy

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Buddhist Tzu Chi General Hospital; Taipei Medical University Hospital; E-DA Hospital; En Chu Kong Hospital
• Investigators: Principal Investigator: Han-Mo Chiu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): January 1, 2009
• Study Completion (Anticipated): January 1, 2009

Study Registration Dates

• First Submitted: September 5, 2008
• First Submitted That Met QC Criteria: September 5, 2008
• First Posted (Estimate): September 8, 2008

Study Record Updates

• Last Update Posted (Estimate): September 8, 2008
• Last Update Submitted That Met QC Criteria: September 5, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: Colonoscopy; Compliance; PEG-ELS; Colon cleansing; Low-reside diet
• Other Study ID Numbers: 200802030R