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INtegrated Colonoscopy Improvement Program in Italy

NCT03661099 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 21250

Last updated 2019-12-18

No results posted yet for this study

Summary

The Italian Society of Digestive Endoscopy (SIED) and the Italian Association of Gastroenterologists and Hospital Digestive Endoscopists (AIGO) want to develop an effective training program for endoscopists to improve the quality of colonoscopies through careful evaluation of quality indicators and how they can be improved with an appropriate educational program. Primary objective of this study is to evaluate the variation of "Polyp Detection Rate (PDR) and Adenoma Detection Rate (ADR)" obtained by operators at high and low volume of colonoscopy before and after a training period. Secondary objectives are to compare high and low volume endoscopists' performance before and after training comparing by evaluation of withdrawal time; Number polyps / patient and Number adenomas / patient; the percentage and time of intubation of the cecum, ; patient's pain perception based on the Nurse Assessed Patient Comfort Score (NAPCOMS) scale. The study is structured as follow:

* A first phase when all endoscopists collect the results of 200 colonoscopies in an electronic Case Report Form (eCRF) is formed(maximum enrollment period 4 months).
* A second phase of training through an e-platform in which the endoscopists are offered with an online refresh reviewing the international standard parameters to perform a quality colonoscopy. Once the final training exam have been passed, the endoscopist will be able to access the third phase
* A third phase in which the endoscopists will collect prospectively the colonoscopies they perform in an eCRF (maximum enrollment period 4 months).

Conditions

  • Colon Lesion
  • Colon Polyp

Interventions

DIAGNOSTIC_TEST

colonoscopy

endoscopists' performance outcome

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2020-12-31
Completion
2021-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03661099 on ClinicalTrials.gov