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

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ClinicalTrials.gov Identifier: NCT00302679
Recruitment Status : Unknown
Verified February 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 14, 2006
Last Update Posted : March 14, 2006
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease Phase
Pain Phase 1

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.

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Defined Population
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Comparison of Colonoscopy and Sigmoidoscopy in Terms of Pain, Acceptance and Procedure Time
Study Start Date : January 2006
Estimated Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

ClinicalTrials.gov Identifier: NCT00302679     History of Changes
Other Study ID Numbers: 9461701245
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: March 14, 2006
Last Verified: February 2006

Keywords provided by National Taiwan University Hospital:
Colonoscopy
Sigmoidoscopy
Colon cancer screening
Pain
Screening