The Comparative Study Between Bowel Preparation Method | NCT01964417

Studies
The Comparative Study Between Bowel Preparation Method

NCT01964417

Sponsor

Inje University

Status

Completed

Last Update Posted

Jan 13, 2014Estimated

Enrollment

319Actual

Phase

Phase 3

Conditions

Colonoscopy

Interventions

Colonoscopy after bowel cleansing

Countries

South Korea

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

Sep 30, 2013

First Submission Date that Met QC Criteria

Oct 14, 2013

First Posted Date

Oct 17, 2013Estimated

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

Jan 9, 2014

Last Update Posted Date

Jan 13, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 the efficacy, acceptability and preparation-induced mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.

Detailed Description

This was a prospective randomized single-blinded clinical trial of ambulatory patients to assess the efficacy of bowel preparation and preparation-induced mucosal inflammation.

Endoscopists who were blinded to the preparation taken, assessed both bowel cleansing by using the Ottawa bowel preparation assessment tool and preparation-induced mucosal inflammation. Acceptability was assessed by questionnaire.

Design Module

Study Type

Interventional

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

319Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
4L-split Dose of PEG Solution	Active Comparator	4L-split Dose of PEG Solution for bowel preparation	Drug: Colonoscopy after bowel cleansing
Low-volume PEG Plus Ascorbic Acid	Active Comparator	Low-volume PEG Plus Ascorbic Acid for bowel preparation	Drug: Colonoscopy after bowel cleansing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colonoscopy after bowel cleansing	Drug		4L-split Dose of PEG Solution Low-volume PEG Plus Ascorbic Acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of colon cleansing between the two solutions using Ottawa scale		3month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who want colonoscopy purposing screening among adults between the age of 20~65

Exclusion Criteria:

Under the age of 20, older than 65, pregnant or lactating women, intestinal obstruction, structural intestinal disease, hypothyroidism, gastrointestinal motility, renal failure, congestive heart failure, liver failure, electrolyte abnormalities, who refused research informed consent, inflammatory bowel disease, the obvious symptoms of the disease in patients with lower gastrointestinal (bloody stools, diarrhea, etc.)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jongha Park, MD	Inje University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haeundae Paik Hospital		Busan		612-896	South Korea