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

NCT ID: NCT00748293

Last Updated: 2008-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-01-31

Brief Summary

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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

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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).

Conditions

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Colonoscopy Colon Cleansing Low-Reside Diet

Keywords

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Colonoscopy Colon cleansing Low-reside diet Compliance PEG-ELS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

PEG-ELS 2000 ml ingestion in the morning of colonoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

B

Low-reside diet on previous day (breakfast, lunch and dinner), PEG-ELS 1500 mL in the morning of colonoscopy

Group Type OTHER

Low-residue diet

Intervention Type OTHER

Commercialized (not yet marketed)low-residue diet

Interventions

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Low-residue diet

Commercialized (not yet marketed)low-residue diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Medical University Hospital

OTHER

Sponsor Role collaborator

E-DA Hospital

OTHER

Sponsor Role collaborator

Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role collaborator

En Chu Kong Hospital

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Taiwan Univesity Hospital

Principal Investigators

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Han-Mo Chiu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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E-DA Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Buddhist Tzu-Chi General Hospital

Taipei, , Taiwan

Site Status RECRUITING

En Chu Kong Hospital

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Han-Mo Chiu, MD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Chi-Yang Chang, MD

Role: primary

Chien-Hwa Chen, MD

Role: primary

Chang-Shyue Yang, MD

Role: primary

Han-Mo Chiu, MD

Role: primary

Chun-Chao Chang, MD

Role: primary

Other Identifiers

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200802030R

Identifier Type: -

Identifier Source: org_study_id