Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

NCT ID: NCT04466696

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2020-07-07

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

t4 colorectal cancer treated with ERAS protocol

prospective from January 2016 to May 2020

ERAS protocol

Intervention Type: BEHAVIORAL

items of ERAS protocol applied

t4 colorectal cancer treated with standards of care

retrospective from January 2010 to December 2015

No interventions assigned to this group

Interventions

ERAS protocol

items of ERAS protocol applied

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rome Tor Vergata

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Sigismondo Sica

Associate Professor, Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id