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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
  Purpose

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.


Condition Intervention
Colonic Polyps
Surveillance
Colonoscopy
 Other: colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Enrollment: 7081
Study Start Date: July 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Colonoscopy patients
Consecutive colonoscopy outpatients referred to one of 29 endoscopy units in Italy
 Other: colonoscopy
evaluation of surveillance timing adequacy as compared to the guidelines

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients referred to one out of 29 endoscopy units in Italy to undergo colonoscopy

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458093

Locations
Italy
Valduce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital
  More Information

No publications provided by Valduce Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Franco Radaelli, Principal Investigator, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01458093     History of Changes
Other Study ID Numbers: SURV_2011
Study First Received: October 18, 2011
Last Updated: October 20, 2011
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colonic Polyps
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 23, 2013