Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Completed

• Conditions: ERAS; Colon Cancer; Fast Track Protocol; T4 Colorectal Cancer
• Interventions: Behavioral: ERAS protocol

• Registration Number: NCT04466696
• Lead Sponsor: University of Rome Tor Vergata

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-05-30
• Study Completion: 2020-07-07
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-09
• Study First Posted: 2020-07-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
t4 colorectal cancer treated with ERAS protocol	ERAS protocol	prospective from January 2016 to May 2020

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay	30 days	number of days from surgery to discharge