Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Overview

Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items. The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together. Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 30, 2020

Interventions

  • Behavioral: ERAS protocol
    • items of ERAS protocol applied

Arms, Groups and Cohorts

  • t4 colorectal cancer treated with ERAS protocol
    • prospective from January 2016 to May 2020
  • t4 colorectal cancer treated with standards of care
    • retrospective from January 2010 to December 2015

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative length of stay
    • Time Frame: 30 days
    • number of days from surgery to discharge

Participating in This Clinical Trial

Inclusion Criteria

  • colorectal cacer – hystologic diagnosis of adenocarcinoma of the colon/rectum – clinically staged T4 – written informed consent to surgery obtained Exclusion Criteria:

  • pregnancy – failure to perform colonic or rectal resection – synchronous cancer at time of colorectal cancer diagnosis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • University of Rome Tor Vergata
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giuseppe Sigismondo Sica, Associate Professor, Head of Department – University of Rome Tor Vergata

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.