CHIRCOLREC: Prospective Database for Colonic or Rectal Resection Surgery Patients

• Sponsor: Institut Paoli-Calmettes (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04704817
• Collaborator: (none)
• Enrollment: 1,000
• Anticipated Duration (Months): 609

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Disorders	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 Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Database for Colonic or Rectal Resection Surgery Patients
• Anticipated Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2051
• Anticipated Study Completion Date: Dec 1, 2071

Outcome Measures

Primary Outcome Measures

1. clinical events [5 years]

   to asses postoperative effects of colonic or rectal excision by collecting clinical events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Institut Paoli-Calmettes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT04704817
• Other Study ID Numbers: CHIRCOLREC-IPC 2018-017
• First Posted: Jan 12, 2021
• Last Update Posted: Jan 12, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 12, 2021