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INtegrated Colonoscopy Improvement Program in Italy

NCT ID: NCT03661099

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

21250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-29

Study Completion Date

2021-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Colon Lesion Colon Polyp

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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colonoscopy

endoscopists' performance outcome

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients between 50 and 75 years old
* colonoscopy for cancer screening program, post polypectomy follow up, patients with abdominal symptoms suggestive for colonic pathology.

Exclusion Criteria

* patients aged \< 50 or \> 75 yrs

* presence of alarm symptoms
* American Society of Anesthesiologists (ASA) Classification ≥ 3
* presence of colonic stenosis
* previous colonic resection
* Presence of diverticulitis
* history of Inflammatory Bowel Disease (IBD)
* History of polyposis syndrome
* Pregnancy or breastfeeding
* inability to provide informed consent
* Severe cardiovascular illness
* contraindication to undergo to sedation
* Anticoagulant therapy
* Melanosis coli
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Pier Alberto Testoni

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pier Alberto Testoni

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Pier Alberto Testoni, MD

Role: CONTACT

Phone: 00390226432756

Email: [email protected]

Facility Contacts

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Pier Alberto Testoni, MD

Role: primary

Other Identifiers

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INCIPIT/2017

Identifier Type: -

Identifier Source: org_study_id