Prospective Database for Colonic or Rectal Resection Surgery Patients (CHIRCOLREC)

Colorectal cancer is the third most common cancer in men, after prostate and lung cancer. It represents 11.2% of all new cases of male cancer. In women, this cancer is the second most common after breast cancer (11.3% of all new cases of female cancer).

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Disorders
• Intervention / Treatment: Other: obsevation

Detailed Description

Colorectal cancer is the second leading cause of cancer death in France. It accounts for nearly 12% of all cancer deaths, especially among those 65 and over. However, mortality has declined steadily since 1980.

Access to screening for colorectal cancer and resection of precancerous lesions partly explains this decline. All sexes combined, it is estimated that about one in five colorectal cancer is diagnosed at a limited local stage. The treatment is then less heavy and gives better results.

With the development of Enhanced Recovery After Surgery (ERAS) protocols and their extension to rectal excision, it becomes imperative to be able to collect operative data from these patients on a perennial basis for the purpose of evaluating our results. Finally, the evaluations resulting from this database could have prognostic value and ultimately allow us to adapt the surgical management of the patient according to the results.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adults treated ot to be treated for colonic and or rectal resection

Description

Inclusion Criteria:

1. Patients treated for colonic and / or rectal resection in the oncological digestive surgery department of the Paoli-Calmettes Institute,
2. Patients over 18 years old,
3. Affiliation to a social security scheme, or beneficiary of such a scheme.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical events	to asses postoperative effects of colonic or rectal excision by collecting clinical events	5 years

Collaborators and Investigators

• Sponsor: Institut Paoli-Calmettes

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): March 1, 2051
• Study Completion (Anticipated): December 1, 2071

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CHIRCOLREC-IPC 2018-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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