Large Overuse of Post-polypectomy Surveillance Colonoscopy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Franco Radaelli, Valduce Hospital

ClinicalTrials.gov Identifier:

NCT01458093

First received: October 18, 2011

Last updated: October 20, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 18, 2011
Last Updated Date	October 20, 2011
Start Date ^ICMJE	July 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 20, 2011)	Adherence to post-polypectomy surveillance guidelines [ Time Frame: up to one year ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01458093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 20, 2011)	Factors associated to surveillance appropriateness [ Time Frame: up to one year ] [ Designated as safety issue: No ] The presence of factors associated to appropriate surveillance prescriptions was investigated by multivariate analysis (odds ratio and 95% confidence interval for each factor)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Large Overuse of Post-polypectomy Surveillance Colonoscopy
Official Title ^ICMJE	Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	All patients referred to one out of 29 endoscopy units in Italy to undergo colonoscopy
Condition ^ICMJE	Colonic Polyps Surveillance Colonoscopy
Intervention ^ICMJE	Other: colonoscopy evaluation of surveillance timing adequacy as compared to the guidelines
Study Group/Cohort (s)	Colonoscopy patients Consecutive colonoscopy outpatients referred to one of 29 endoscopy units in Italy Intervention: Other: colonoscopy
Publications *	Radaelli F, Paggi S, Bortoli A, De Pretis G; Italian Association of Hospital Gastroenterologists (AIGO). Overutilization of post-polypectomy surveillance colonoscopy in clinical practice: a prospective, multicentre study. Dig Liver Dis. 2012 Sep;44(9):748-53. Epub 2012 May 22.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	7081
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01458093
Other Study ID Numbers ^ICMJE	SURV_2011
Has Data Monitoring Committee	No
Responsible Party	Franco Radaelli, Valduce Hospital
Study Sponsor ^ICMJE	Valduce Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Valduce Hospital
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top