Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test (ColonoScopy)

Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test: Study of Practices in the Grand-Est

In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Jean-Marie REIMUND, MD, PhD; Phone Number: 33 3 88 12 74 41; Email: jean-marie.reimund@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg
    • Contact: Jean-Marie REIMUND, MD, PhD; Phone Number: 33 3 88 12 74 41; Email: jean-marie.reimund@chru-strasbourg.fr
    • Principal Investigator: Jean-Marie REIMUND, MD, PhD
    • Sub-Investigator: Isabelle GENDRE, MD
    • Sub-Investigator: Victor NARDON, MD
    • Sub-Investigator: Bénédicte CARON, MD
    • Sub-Investigator: Myriam GUERBAZ, MD
    • Sub-Investigator: Maurice TANGUY, MD
    • Sub-Investigator: Joël LACROUTE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subject aged between 50 and 75 years old at the time of the colonoscopy with incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR

Description

Inclusion criteria:

• Age between 50 and 75 years old at the time of the colonoscopy
• With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR
• Patient whose follow-up has ended
• Patient living in the Grand-Est region and in the department of the site concerned
• Examination carried out by a gastroenterologist from the Grand-Est region
• Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

• Age ≥ 76 years at the time of colonoscopy
• Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)
• Colonoscopy performed before the fecal immunological test
• Gastroenterologist performing the examination practicing outside the Grand-Est region
• Subject not able to understand the objectives of this research
• Subject under judicial control
• Subject under tutorship or curatorship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test	Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): April 16, 2022

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: December 10, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Colorectal cancer; Colonoscopy; Immunological test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 8090

Drug and device information, study documents

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