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NCT04594655 Clinical Trial

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

Colorectal Cancer Clinical Trial

— MPI;CRC  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04594655
Other study ID # 2803
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date September 30, 2019

Study information
Verified date October 2020
Source Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date September 30, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery
colectomy

Locations
Country Name City State
Italy ASST Spedali Civili Brescia Lombardia

Sponsors (1)
Lead Sponsor Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
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