Colon LesionincipitNCT03661099
INtegrated Colonoscopy Improvement Program in Italy
An observational study of Colon Lesion and Colon Polyp, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colon Lesion, Colon Polyp
- What is being tested?
- colonoscopy
- How many people
- 21,250 participants
- Where
- 1 siteItaly
- Study dates
- 29 Aug 2018to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- patients between 50 and 75 years old
- colonoscopy for cancer screening program, post polypectomy follow up, patients with abdominal symptoms suggestive for colonic pathology.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Pier Alberto Testoni
Milan, 20132
Pier Alberto Testoni, MD, 00390226432756
About this study
Official title: 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).
- Conditions
- Colon Lesion, Colon Polyp
- Being tested
- colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyDiagnostic test
endoscopists' performance outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
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)"
Measured: 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
Measured: 9 months
Secondary outcomes (6)
Withdrawal time
to evaluate the amount of time spent viewing during the withdrawal of the scope
Measured: 9 months
Number polyps / patient
Number of polyps found in each patient
Measured: 9 months
Number adenomas / patient
Number of adenomas found in each patient
Measured: 9 months
percentage of intubation of the cecum
percentage of colonoscopy in which endoscopist reach cecum
Measured: 9 months
time of intubation of the cecum
the amount of time spent by endoscopist to reach cecum
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start29 Aug 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon LesionStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pier Alberto Testoni, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661099
- Sponsor's protocol ID
- INCIPIT/2017
- Acronym
- incipit
- Status last verified
- Dec 2019
- First submitted
- 29 Aug 2018
- Last updated
- 18 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INtegrated Colonoscopy Improvement Program in Italy (INCIPIT)
- ClinicalTrials.gov ID
- NCT03661099
- Acronym / sponsor ID
- incipit / INCIPIT/2017
- Conditions
- Colon Lesion, Colon Polyp
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21,250 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- patients between 50 and 75 years old
- colonoscopy for cancer screening program, post polypectomy follow up, patients with abdominal symptoms suggestive for colonic pathology.
Key exclusion criteria (14 listed)
- patients aged < 50 or > 75 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopyendoscopists' performance outcome | Diagnostic test | – |
Primary outcome
Adenoma detection rate
Time frame: 9 months
to evaluate Adenoma Detection Rate obtained by operators at high and low volume of colonoscopy before and after a training period(ADR)"
Polyps detection rate
Time frame: 9 months
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
6 secondary outcomes
Withdrawal time
Time frame: 9 months
Number polyps / patient
Time frame: 9 months
Number adenomas / patient
Time frame: 9 months
percentage of intubation of the cecum
Time frame: 9 months
time of intubation of the cecum
Time frame: 9 months
patient's pain perception assessed by Nurse Assessed Patient Comfort Score (NAPCOMS)
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Lesion and Colon Polyp, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pier Alberto Testoni, MD (00390226432756, testoni.pieralberto@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.