INtegrated Colonoscopy Improvement Program in Italy (incipit)

INtegrated Colonoscopy Improvement Program in Italy (INCIPIT)

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).

Study Overview

• Status: Unknown
• Conditions: Colon Polyp; Colon Lesion
• Intervention / Treatment: Diagnostic test: colonoscopy

• Study Type: Observational
• Enrollment (Anticipated): 21250

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • Pier Alberto Testoni
    • Contact: Pier Alberto Testoni, MD; Phone Number: 00390226432756

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal time	to evaluate the amount of time spent viewing during the withdrawal of the scope	9 months
Number polyps / patient	Number of polyps found in each patient	9 months
Number adenomas / patient	Number of adenomas found in each patient	9 months
percentage of intubation of the cecum	percentage of colonoscopy in which endoscopist reach cecum	9 months
time of intubation of the cecum	the amount of time spent by endoscopist to reach cecum	9 months
patient's pain perception assessed by Nurse Assessed Patient Comfort Score (NAPCOMS)	evaluate tolerability of colonoscopy. NAPCOMS includes 3 domains: pain, sedation, and a global subjective assessment of tolerability. The pain domain is defined by using the dimensions of intensity (0. None or minimal; 1 mild; 2. Moderate; 3 severe), frequency (0. None; 1. Few 1 or 2 episodes; 2. Several times (3-4 episodes); 3. Frequent); and duration (0. None; 1 short duration; 2 Moderate duration; 3 Long duration). Sedation is rated according to level of consciousness ranging from 0 (wide awake) to 3 (unconscious), whereas the global tolerability score is rated from 0 (very well tolerated) to 3 (poorly tolerated). The overall NAPCOMS was defined as the sum of the severity, frequency, and duration of pain domains. Level of sedation and overall global tolerability ratings were assessed separately A NAPCOMS of 6 or greater corresponded with a patient rating of moderate to severe discomfort.	9 months

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Colonic Polyps
• Other Study ID Numbers: INCIPIT/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No