MPI Predicts Outcome of CRC Elderly Patients (MPI=MULTIDIMENSIONAL PROGNOSTIC INDEX; CRC=COLORECTAL CANCER) (MPI;CRC)

October 17, 2020 updated by: Giacomo Pata, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Multidimensional Prognostic Index (MPI) Score Has the Major Impact on Outcome Prediction in Elderly Surgical Patients With Colorectal Cancer: the Fragis Study

Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The importance of this report is that MPI-score resulted strongly associated with major complications and it was a primary component of an individual prediction model.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: surgery

Detailed Description

Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The MPI (multidimensional prognostic index)-score resulted strongly associated with major complications. also, it was a primary component of an individual prediction model (LASSO model).

Study Type

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- Lombardia
  - Brescia, Lombardia, Italy, 25100
    - ASST Spedali Civili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CRC patients aged ≥75 years

Description

Inclusion Criteria:

All CRC patients aged ≥75 years, who were scheduled for elective surgery and able to express their consent to treatment, were considered.

Exclusion Criteria: emergency surgery; patients aged <75 years; patients unable to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPI and major morbidity Time Frame: 30 days	The primary goal of the FRAGIS (Frailty Assessment by Geriatric Investigation in Surgery) study was to evaluate the association between the MPI score and the occurrence of major postoperative complications within 30 days of CRC surgery.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of complication Time Frame: 90 days	The secondary goal was to develop a model to predict the individual risk of postoperative complications, allowing the appropriate patient selection for surgery.	90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Investigators

Study Chair: Uberto Fumagalli, MD, ASST Spedali Civili di Brescia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

October 11, 2020

First Submitted That Met QC Criteria

October 17, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)