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

NCT05172713 | Unknown

• 1 other identifier: 8090
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer; Immunological test; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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]

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jean-Marie REIMUND, MD, PhD

CONTACT

33 3 88 12 74 41; jean-marie.reimund@chru-strasbourg.fr

Saïd CHAYER, PhD, HDR

CONTACT

said.chayer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: December 29, 2021
• Study Start: January 16, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 16, 2022
• Last Updated: December 29, 2021

Record last verified: 2021-10

Locations

FR (1)