Large Overuse of Post-polypectomy Surveillance Colonoscopy

Colonoscopy Clinical Trial

Official title:

Large Overuse of Post-polypectomy Surveillance Colonoscopy: a Prospective Nation-wide Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458093
• Other study ID #: SURV_2011
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: October 20, 2011
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: October 2011
• Source: Valduce Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7081
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Polyps
• Colonoscopy
• Surveillance

Intervention

Other:
• colonoscopy
evaluation of surveillance timing adequacy as compared to the guidelines

Locations

Country	Name	City	State
Italy	Valduce Hospital	Como

Sponsors (1)

Lead Sponsor	Collaborator
Valduce Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to post-polypectomy surveillance guidelines	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	No
Secondary	Factors associated to surveillance appropriateness	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	No