NCT03661099

Brief 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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
21,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 29, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

August 29, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

December 18, 2019

Status Verified

December 1, 2019

Enrollment Period

2.3 years

First QC Date

August 29, 2018

Last Update Submit

December 17, 2019

Conditions

Colon LesionColon Polyp

Outcome Measures

Primary Outcomes (2)

  • Adenoma detection rate

    to evaluate Adenoma Detection Rate obtained by operators at high and low volume of colonoscopy before and after a training period(ADR)"

    9 months

  • Polyps detection rate

    to evaluate the variation of "Polyp Detection Rate (PDR) obtained by operators at high and low volume of colonoscopy before and after a training period

    9 months

Secondary Outcomes (6)

  • Withdrawal time

    9 months

  • Number polyps / patient

    9 months

  • Number adenomas / patient

    9 months

  • percentage of intubation of the cecum

    9 months

  • time of intubation of the cecum

    9 months

  • +1 more secondary outcomes

Interventions

colonoscopyDIAGNOSTIC_TEST

endoscopists' performance outcome

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged between 50 and 75 years old who present with abdominal symptoms suggestive for colonic patholgy or included in cancer screening program

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pier Alberto Testoni

Milan, 20132, Italy

RECRUITING

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

Central Study Contacts

Pier Alberto Testoni, MD

CONTACT

00390226432756testoni.pieralberto@hsr.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 29, 2018

First Posted

September 7, 2018

Study Start

August 29, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

December 18, 2019

Record last verified: 2019-12

Locations

IT(1)