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

Colorectal Cancer Clinical Trial

— ColonoScopy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05172713
• Other study ID #: 8090
• Status: Recruiting
• Start date: January 16, 2021
• Est. completion date: April 16, 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Strasbourg, France
• Contact: Jean-Marie REIMUND, MD, PhD
• Phone: 33 3 88 12 74 41
• Email: jean-marie.reimund[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 16, 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
France	Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]