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NCT01964417 Clinical Trial

The Comparative Study Between Bowel Preparation Method

Colonoscopy Clinical Trial

— CSBPM  

Official title:
The Comparative Study Between Bowel Preparation Method: 4L-split Dose of PEG Solution, Low-volume PEG Plus Ascorbic Acid Focusing on the Bowel Cleansing Efficacy, Patients' Affinity to Preparation Solution and Mucosal Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01964417
Other study ID # PEG-0488
Secondary ID
Status Completed
Phase Phase 3
First received September 30, 2013
Last updated January 9, 2014
Start date September 2013
Est. completion date January 2014

Study information
Verified date January 2014
Source Inje University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 319
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 65 Years
Eligibility 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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• Colonoscopy after bowel cleansing

Locations
Country Name City State
Korea, Republic of Haeundae Paik Hospital Busan

Sponsors (1)
Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of colon cleansing between the two solutions using Ottawa scale 3month No
See also
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Recruiting NCT00160823 - Impact of a Self-Administered Information Leaflet on Adequacy of Colonic Cleansing for in-Hospital Patients Phase 3
Completed NCT00314418 - Patient Position and Impact on Colonoscopy Time N/A
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Completed NCT00427089 - Comparison of 2L NRL994 With NaP Preparation in Colon Cleansing Prior to Colonoscopies for Colon Tumor Screening Phase 3
Completed NCT00209573 - A Study of AQUAVAN® Injection Versus Midazolam HCl for Sedation in Patients Undergoing Elective Colonoscopy Phase 3
Completed NCT05823350 - The Effect of Abdominal Massage on Pain and Distention After Colonoscopy N/A
Completed NCT05076799 - Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures Phase 3