Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

NCT04466696 | Completed

• 1 other identifier: 3
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

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.

Conditions

T4 Colorectal Cancer; ERAS; Colon Cancer; Fast Track Protocol

Keywords

colon cancer; ERAS; fast track; t4 colorectal cancer; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Postoperative length of stay

  number of days from surgery to discharge

  30 days

Study Arms (2)

t4 colorectal cancer treated with ERAS protocol

prospective from January 2016 to May 2020

Behavioral: ERAS protocol

t4 colorectal cancer treated with standards of care

retrospective from January 2010 to December 2015

Interventions

ERAS protocol BEHAVIORAL

items of ERAS protocol applied

t4 colorectal cancer treated with ERAS protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Department

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: January 1, 2016
• Primary Completion: May 30, 2020
• Study Completion: July 7, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12