Comparison of Colonoscopy and Sigmoidoscopy in Terms of Pain, Acceptance and Procedure Time

This study is currently recruiting participants.

Verified by National Taiwan University Hospital, February 2006

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00302679

Purpose

According to experience in a self-payed health check-up center,unsedated total colonoscopy is not inferior or may be better than unsedated sigmoidoscopy in terms of pain and patients' acceptance.

Hypothesis: Unsedated total colonoscopy is not inferior to unsedated sigmoidoscopy in terms of pain and patients' acceptance.

Condition	Phase
Pain	Phase I

U.S. FDA Resources

Study Type:	Observational
Study Design:	Psychosocial, Cross-Sectional, Defined Population, Prospective Study
Official Title:	Comparison of Colonoscopy and Sigmoidoscopy in Terms of Pain, Acceptance and Procedure Time

Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment:	400
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2006

Detailed Description:

According to American Cancer Society guideline, screening total colonoscopy every 10 years or sigmoidoscopy every 5 years is recommended for average risk people above 50 years old. However,study in Taiwanese population demonstrated that 37.8% of colorectal lesions were beyond reach of sigmoidoscope, and in cases with lesions with advanced pathology, 66.7% did not have distal colorectal lesion. However, many people think colonoscopy is more painful and choose sigmoidoscopy for screening. However, according to experience in a self-payed health check-up center,unsedated total colonoscopy is not inferior or may be better than unsedated sigmoidoscopy in terms of pain and patients' acceptance.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who undergo self-payed unsedated colonoscopy or sigmoidoscopy for colon cancer screening.

Exclusion Criteria:

Difficulty in assessing pain during the procedure and acceptance for the procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302679

Contacts

Contact: Wei Chih Liao, MD

886-2-23123456 ext 3356

david.ntuh@msa.hinet.net

Locations

Taiwan
National Taiwan University Hospital	Recruiting
Taipei, Taiwan, 100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator:

Wei Chih Liao, MD

National Taiwan University Hospital

More Information

Publications:

1. Smith RA, Cokkinides V, Eyre HJ. American Cancer Society guidelines for the early detection of cancer, 2004. CA Cancer J Clin 2004;54:41-52. 2. Labianca R, Beretta GD, Mosconi S, Milesi L, Pessi MA. Colorectal cancer: screening. Ann Oncol 2005;16 Suppl 2:ii127-32. 3. Wallace MB, Kemp JA, Trnka YM, Donovan JM, Farraye FA. Is colonoscopy indicated for small adenomas found by screening flexible sigmoidoscopy? Ann Intern Med 1998;129:273-8. 4. Eddy DM. Screening for colorectal cancer. Ann Intern Med 1990;113:373-84. 5. Chiu HM, Wang HP, Lee YC, Huang SP, Lai YP, Shun CT, Chen MF, Wu MS, Lin JT. A prospective study of the frequency and the topographical distribution of colon neoplasia in asymptomatic average-risk Chinese adults as determined by colonoscopic screening. Gastrointest Endosc 2005;61:547-53. 6. Imperiale TF, Wagner DR, Lin CY, Larkin GN, Rogge JD, Ransohoff DF. Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings. N Engl J Med 2000;343:169-74. 7. Nicholson FB, Korman MG. Acceptance of flexible sigmoidoscopy and colonoscopy for screening and surveillance in colorectal cancer prevention. J Med Screen 2005;12:89-95.

Study ID Numbers:	9461701245
Study First Received:	March 12, 2006
Last Updated:	March 13, 2006
ClinicalTrials.gov Identifier:	NCT00302679
Health Authority:	Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:

Colonoscopy
Sigmoidoscopy
Colon cancer screening
Pain
Screening

Study placed in the following topic categories:

Pain

ClinicalTrials.gov processed this record on January 16, 2009