Adenoma Detection Rate With Position Change at Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
North West London Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00234650
First received: October 5, 2005
Last updated: April 1, 2009
Last verified: December 2008
  Purpose

The hypothesis to be tested is that position changes during the withdrawal phase of colonoscopy leads to a higher adenoma (polyp) detection rate because of better distension of the colon. Since adenomas are precancerous lesions the enhanced adenoma detection will increase the success of colorectal cancer screening programmes. This study will provide evidence for the value of position changes and encourage endoscopist to adopt position change as a routine in their practice.

May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV).


Condition Intervention
Polyps
Procedure: Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Evaluation of the Effect of Position Change During the Withdrawal Phase of Colonoscopy on Adenoma Detection Rate

Resource links provided by NLM:


Further study details as provided by North West London Hospitals NHS Trust:

Primary Outcome Measures:
  • adenoma detection rate for position 1 compared to position 2

Secondary Outcome Measures:
  • percentage of adenomas detected in all the participants for each position

Estimated Enrollment: 130
Study Start Date: October 2005
Study Completion Date: September 2007
Detailed Description:

Colorectal cancer is the second commonest cause of cancer death. In a majority of cases it is preceded by a precancerous lesion called an adenoma (commonly known as polyp). Detection and removal of adenomas at colonoscopy has been shown to reduce mortality from colorectal cancer. The success of the impending colorectal cancer screening programme to reduce cancer mortality in an average-risk population depends on optimal adenoma detection at colonoscopy. The detection of adenomas has been shown to vary between different endoscopist. Some of the factors that have been reported to affect adenoma detection rates included the time spent viewing, the adequacy of the bowel preparation and the time spent cleaning the colonic mucosa of excess fluid. Careful examination of proximal side of flexures, folds and valves by the endoscopist is equally important. However, even with careful examination adenoma detection rates have been shown to vary between endoscopist from 8.6% to 15.9%. Previous experience and training may be contributed to this difference. Some endoscopist adopt regular changes in position during the procedure to maximize distension of the colon. Better luminal distension enhances mucosal views for detection of the smaller adenomas. The validity of this approach has never been tested and we propose that this factor may contribute to the differences in adenoma detection rates.

Patients will be randomised to either position 1 first then position 2 or vice versa and examined twice. During one withdrawal the colon will be examined with the participant in the left lateral position only (position 1) or with position changes (position 2)or vice versa.

May 2007: protocol amendment to include additional prospective analysis using High Definition TV (HDTV). No further patient data collection involved.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred ot colonoscopy, age between 50 - 70 years

Exclusion Criteria:

  • Patients with colorectal cancer, previous colonic surgery, active colitis and musculoskeletal problems Patients may also be excluded after the first insertion, if painful, routine care will proceed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234650

Locations
United Kingdom
North West London NHS Trust
London, Middlesex, United Kingdom, HA1 3UJ
Sponsors and Collaborators
North West London Hospitals NHS Trust
Investigators
Principal Investigator: Brian Saunders, MD St Mark's Hospital, North West London NHS Trust
  More Information

Additional Information:
No publications provided by North West London Hospitals NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00234650     History of Changes
Other Study ID Numbers: 05/CO05/15
Study First Received: October 5, 2005
Last Updated: April 1, 2009
Health Authority: United Kingdom: National Health Service

Keywords provided by North West London Hospitals NHS Trust:
position change
adenoma
colonoscopy

Additional relevant MeSH terms:
Adenoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 23, 2014