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

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: Colorectal Cancer; Elderly; Fragility
• 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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPI and major morbidity	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	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

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Investigators: Study Chair: Uberto Fumagalli, MD, ASST Spedali Civili di Brescia

Study record dates

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): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 17, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No