Large Overuse of Post-polypectomy Surveillance Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458093
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : October 24, 2011
Information provided by (Responsible Party):
Franco Radaelli, Valduce Hospital

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.

Condition or disease Intervention/treatment
Colonic Polyps Surveillance Colonoscopy Other: colonoscopy

Study Type : Observational
Actual Enrollment : 7081 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study
Study Start Date : July 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01458093

Valduce Hospital
Como, Italy, 22100
Sponsors and Collaborators
Valduce Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Franco Radaelli, Principal Investigator, Valduce Hospital Identifier: NCT01458093     History of Changes
Other Study ID Numbers: SURV_2011
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: October 24, 2011
Last Verified: October 2011

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