Comparison of Bowel Cleansing Methods for Colonoscopy in... | NCT01528098

Studies
Comparison of Bowel Cleansing Methods for Colonoscopy in Hospitalized Patients

NCT01528098

Sponsor

Kangbuk Samsung Hospital

Status

Unknown status

Last Update Posted

Feb 22, 2012Estimated

Enrollment

600Estimated

Phase

Not provided

Conditions

Intestine; Complaints

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

Jul 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Feb 3, 2012

First Submission Date that Met QC Criteria

Feb 3, 2012

First Posted Date

Feb 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dong Il Park, M.D, Ph.D., Associate professor, Department of Internal Medicine, Kangbuk Samsung HospitalPrincipal Investigator

Lead Sponsor

Kangbuk Samsung HospitalOTHER

Collaborators

Name	Class
Soon Chun Hyang University	OTHER
Kyunghee University	OTHER
Hanyang University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare two regimens of polyethylene glycol(PEG) plus bisacodyl versus PEG alone for bowel preparation in hospitalized patients.

Detailed Description

Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated, especially in hospitalized patients who had comorbidity and restricted ambulation. Recently, a new PEG-based bowel cleansing agents became available. It combines PEG with a high dose of ascorbic acid or bisacodyl. Although many studies reported the efficacy of these combined solution for colonoscopy, but efficacy in hospitalized patients was under-recognized.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PEG plus bisacodyl		Those who taken PEG 4L + bisacodyl 10mg
PEG 4L		Those who taken PEG 4L alone

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The efficacy of bowel preparation	Ottawa scale	one day (after colonoscopy)

Secondary Outcomes

Measure	Description	Time Frame
Patient's compliance and acceptability	acceptability, Visual Analogue Scale	one day (after injestion of preparation solution)
Patient's compliance and acceptability (2)	stress for ingestion, Stress 0(not) - 4(severe)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized patients for colonoscopy

Exclusion Criteria:

age under 20 years or over 80 years
major psychiatric illness
known allergy to PEG
serious condition- severe cardiac, renal, or metabolic diseases
partial colon resection
current acute exacerbation of chronic inflammatory bowel disease
functional constipation defined by Rome III diagnostic criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Hospitalized patients for colonoscopy in university hospital.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Dong Il Park, professor	Contact	82-2-2001-2059		diksmc.park@samsung.com

Overall Officials

Name	Affiliation	Role
Dong Il Park, Professor	Kangbuk Samsung Hospital	Principal Investigator

Locations

Not provided