NCT00748293

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

September 8, 2008

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

September 5, 2008

Last Update Submit

September 5, 2008

Conditions

ColonoscopyColon CleansingLow-Reside Diet

Keywords

ColonoscopyColon cleansingLow-reside dietCompliancePEG-ELS

Outcome Measures

Primary Outcomes (1)

  • Colon cleansing level

    At the timing of colonoscopy

Secondary Outcomes (4)

  • 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

Study Arms (2)

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

Other: Low-residue diet

Interventions

Low-residue dietOTHER

Commercialized (not yet marketed)low-residue diet

B

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects who receives colonoscopy for screening or for clinical purpose

You may not qualify if:

  • Subjects with polyposis, ileus, active GI bleeding, IBD, severe constipation, renal insufficiency, obesity with BMI≥30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

E-DA Hospital

Kaohsiung City, Taiwan

RECRUITING

Buddhist Tzu-Chi General Hospital

Taipei, Taiwan

RECRUITING

En Chu Kong Hospital

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Han-Mo Chiu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Han-Mo Chiu, MD

CONTACT

886-2-23123456hanmochiu@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 8, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

September 8, 2008

Record last verified: 2008-09

Locations

TW(5)