NCT01740518

Brief Summary

The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-patients

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

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

March 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 4, 2012

Completed
Last Updated

December 4, 2012

Status Verified

November 1, 2012

Enrollment Period

9 months

First QC Date

November 30, 2012

Last Update Submit

November 30, 2012

Conditions

Colonoscopy [E01.370.372.250.250.200]

Outcome Measures

Primary Outcomes (1)

  • The efficacy of bowel preparation

    three segmental preparation scoring (0\~4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid

    one day (after colonoscopy)

Secondary Outcomes (1)

  • Patient's compliance and acceptability

    one day (after injestion of preparation solution)

Study Arms (2)

PEG + ascorbic acid

Those who taken PEG 2L + ascorbic acid

Drug: polyethylene glycol, ascorbic acid

PEG 4L

Those who taken PEG 4L alone

Interventions

polyethylene glycol, ascorbic acidDRUG

comparison of different solutions for bowel preparation

PEG + ascorbic acid

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out-patients for colonoscopy in university hospital

You may qualify if:

  • Out-patients for colonoscopy

You may not qualify if:

  • age under 19 years or over 80 years
  • Intestinal obstruction
  • Women of pregnant, breastfeeding, or at risk of becoming pregnant
  • major psychiatric illness
  • known allergy to PEG
  • serious condition- severe cardiac, renal, or metabolic diseases
  • past history of colon resection
  • current acute exacerbation of chronic inflammatory bowel disease
  • functional constipation defined by Rome III diagnostic criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, Seoul, 110-746, South Korea

Location

Related Links

MeSH Terms

Interventions

Polyethylene GlycolsAscorbic Acid

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureSugar AcidsAcids, AcyclicCarboxylic AcidsHydroxy AcidsCarbohydrates

Study Officials

  • Dong Il Park, professor

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 4, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2012

Last Updated

December 4, 2012

Record last verified: 2012-11

Locations

KR(1)