Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

December 24, 2020 updated by: Giuseppe Sigismondo Sica, University of Rome Tor Vergata

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a clinical diagnosis of stage T4 colorectal cancer who underwent surgical resection between January 2016 to January 2020 at Minimally Invasive Surgery Unit of Tor Vergata University Hospital were prospectively enrolled in the ERAS group and treated with fast track protocol. Postoperative short outcomes were compared to a control group treated with conventional care that underwent surgical resection for T4 colorectal cancer at the same center from January 2010 to December 2015. Data of the control group were collected retrospectively from a prospectively mantained database.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
t4 colorectal cancer treated with ERAS protocol
prospective from January 2016 to May 2020
Behavioral: ERAS protocol
items of ERAS protocol applied
t4 colorectal cancer treated with standards of care
retrospective from January 2010 to December 2015

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative length of stay
Time Frame: 30 days
number of days from surgery to discharge
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

May 30, 2020

Study Completion (ACTUAL)

July 7, 2020

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 9, 2020

First Posted (ACTUAL)

July 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 29, 2020

Last Update Submitted That Met QC Criteria

December 24, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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