- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00302679
Comparison of Colonoscopy and Sigmoidoscopy in Terms of Pain, Acceptance and Procedure Time
March 13, 2006 updated by: National Taiwan University Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment
400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Other
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Wei Chih Liao, MD, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion
December 7, 2022
Study Completion
June 1, 2006
Study Registration Dates
First Submitted
March 12, 2006
First Submitted That Met QC Criteria
March 13, 2006
First Posted (Estimate)
March 14, 2006
Study Record Updates
Last Update Posted (Estimate)
March 14, 2006
Last Update Submitted That Met QC Criteria
March 13, 2006
Last Verified
February 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- 9461701245
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey