NCT01458093

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,081

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
Last Updated

October 24, 2011

Status Verified

October 1, 2011

Enrollment Period

6 months

First QC Date

October 18, 2011

Last Update Submit

October 20, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Factors associated to surveillance appropriateness

    up to one year

Study Arms (1)

Colonoscopy patients

Consecutive colonoscopy outpatients referred to one of 29 endoscopy units in Italy

Other: colonoscopy

Interventions

evaluation of surveillance timing adequacy as compared to the guidelines

Colonoscopy patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • consecutive colonoscopy outpatients
  • adults (18-80 yrs)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valduce Hospital

Como, 22100, Italy

Location

Related Publications (1)

  • 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. doi: 10.1016/j.dld.2012.04.015. Epub 2012 May 22.

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 18, 2011

First Posted

October 24, 2011

Study Start

July 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

October 24, 2011

Record last verified: 2011-10

Locations