INtegrated Colonoscopy Improvement Program in Italy

Colon Polyp Clinical Trial

— incipit  

Official title:

INtegrated Colonoscopy Improvement Program in Italy (INCIPIT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03661099
• Other study ID #: INCIPIT/2017
• Status: Recruiting
• Start date: August 29, 2018
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: IRCCS San Raffaele
• Contact: Pier Alberto Testoni, MD
• Phone: 00390226432756
• Email: testoni.pieralberto[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21250
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Lesion
• Colon Polyp
• Colonic Polyps

Intervention

Diagnostic Test:
• colonoscopy
endoscopists' performance outcome

Locations

Country	Name	City	State
Italy	Pier Alberto Testoni	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Withdrawal time	to evaluate the amount of time spent viewing during the withdrawal of the scope	9 months
Secondary	Number polyps / patient	Number of polyps found in each patient	9 months
Secondary	Number adenomas / patient	Number of adenomas found in each patient	9 months
Secondary	percentage of intubation of the cecum	percentage of colonoscopy in which endoscopist reach cecum	9 months
Secondary	time of intubation of the cecum	the amount of time spent by endoscopist to reach cecum	9 months
Secondary	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