- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458093
Large Overuse of Post-polypectomy Surveillance Colonoscopy
Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study
In colorectal cancer screening era a huge burden of medical resources has been applied to surveillance. Although the adherence to post-polipectomy recommendations is a advocated as a mainstay for quality assurance colonoscopy programs, prospective data on appropriateness of surveillance are lacking.
The aim of present study was to evaluate the percentage of subjects in which timing of surveillance colonoscopy in practice agrees with that recommended by guidelines and to identify factors associated to the appropriateness of surveillance.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Como, Italy, 22100
- Valduce Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- consecutive colonoscopy outpatients
- adults (18-80 yrs)
Exclusion Criteria:
- Subjects with missing data on polyp findings at previous colonoscopy (number, endoscopic or histological features)
- Subjects with unsatisfactory quality standards of previous examination (no cecal intubation, inadequate bowel preparation, incomplete polyp resection)
- patients with a medical history of inflammatory bowel disease, inherited or other polyposis syndrome and colorectal cancer.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Colonoscopy patients
Consecutive colonoscopy outpatients referred to one of 29 endoscopy units in Italy
|
evaluation of surveillance timing adequacy as compared to the guidelines
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to post-polypectomy surveillance guidelines
Time Frame: up to one year
|
Time interval between index and surveillance colonoscopies for patients undergoing post-polypectomy surveillance was calculated and compared to that suggested by the guidelines according to endoscopic findings at previous examination.
For each patiens, surveillance time interval was regarded as correct if coherent with the recommended interval +/- 6 months, thus allowing to calculate the proportion of correct prescriptions
|
up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Factors associated to surveillance appropriateness
Time Frame: up to one year
|
The presence of factors associated to appropriate surveillance prescriptions was investigated by multivariate analysis (odds ratio and 95% confidence interval for each factor)
|
up to one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SURV_2011
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