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NCT04466696 Clinical Trial

Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Colon Cancer Clinical Trial

Official title:
Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04466696
Other study ID # 3
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date July 7, 2020

Study information
Verified date December 2020
Source University of Rome Tor Vergata
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date July 7, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• ERAS protocol
items of ERAS protocol applied

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Rome Tor Vergata

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative length of stay number of days from surgery to discharge 30 days
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