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Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients

NCT ID: NCT04466696

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2020-07-07

Brief Summary

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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

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Conditions

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T4 Colorectal Cancer ERAS Colon Cancer Fast Track Protocol

Keywords

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colon cancer ERAS fast track t4 colorectal cancer colorectal cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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ERAS protocol

items of ERAS protocol applied

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

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University of Rome Tor Vergata

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Sigismondo Sica

Associate Professor, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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3

Identifier Type: -

Identifier Source: org_study_id