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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00302679
• Other study ID #: 9461701245
• Status: Recruiting
• Phase: Phase 1
• First received: March 12, 2006
• Last updated: March 13, 2006
• Start date: January 2006
• Est. completion date: June 2006

Study information

• Verified date: February 2006
• Source: National Taiwan University Hospital
• Contact: Wei Chih Liao, MD
• Phone: 886-2-23123456
• Email: david.ntuh[@]msa.hinet.net
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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.