The Effect of Bowel Preparation Status on the Polyp Missing Rate

Colonoscopy Clinical Trial

Official title:

The Effect of Bowel Preparation Status on the Polyp Missing Rate During Colonoscopy: Prospective Study Using Tandem Colonoscopic Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988676
• Other study ID #: KUH1010135
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: April 19, 2010
• Start date: May 2009
• Est. completion date: March 2010

Study information

• Verified date: October 2009
• Source: Konkuk University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial Summary

High quality bowel cleaning preparation was most important prerequisites of a accurate colonoscopy, because even a small amount of residual fecal matter can obscure small polyps and increase unnecessary procedure time. Until now, several studies evaluated the impact of bowel preparation on the quality of colonoscopy using comparison of the polyp detection rate in patients with adequate bowel preparation status to that in patients with inadequate bowel preparation status during colonoscopy. However, there was no direct measurement the effect bowel preparation status on the polyp missing rate, the quality of colonoscopy, using tandem colonoscopic evaluation in prospective setting.

Description:

1. Study flow

1. All patients perform Colonoscopy

• record the polyp size, shape, location and number

• record the factors affecting polyp missing rate

• Patients' age / gender

• Indication of colonoscopy

• colonoscopist career

• colonoscopy withdrawal time

• bowel preparation status according to scale of U.S. Multi-Society Task Force on colorectal cancer, Aronchick's scale and Ottawa bowel preparation quality scale

2. the patients needed or wanted to 2nd stage colonoscopic polypectomy (2nd stage polypectomy was performed within 6 month)

• record additionally detected polyp - size, shape, location and number

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• The patients underwent colonoscopy and 2nd stage colonoscopic polypectomy at Konkuk University Medical Center

Exclusion Criteria:

• Colonoscopy was not reached the caecum

• The patients with 10 or more polyps (who suspected polyposis syndrome)

• Bowel preparation was inadequate when 2nd stage colonoscopic polypectomy

• The patients with inflammatory bowel disease or suspected inflammatory bowel disease

• The patients had a history of bowel resection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Colorectal Polyps
• Polyp Missing Rate
• Polyps

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Konkuk University Hospital	Konkuk University, Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of,