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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04538404
Other study ID # MECC Score
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2011
Est. completion date January 31, 2019

Study information

Verified date August 2020
Source University of Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

CR-POSSUM is one of the most used surgical scores to predict mortality after colorectal surgery. Its main drawback is the requirement of intraoperative variables, whose collection is time-consuming and prevents from obtaining a purely preoperative risk assessment. The primary aim of the study is to develop a new surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population. The secondary objective is to analyze its efficacy compared to CR-POSSUM.


Description:

Patients aged 80 and older undergoing surgery for colon cancer from 2011 to 2017 in an Italian hospital were retrospectively selected. MECC score [Mortality in Elderly patients with Colon Cancer] was calculated summing up the scores relating to: arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine. Once CR-POSSUM was calculated, the two scores were compared.


Recruitment information / eligibility

Status Completed
Enrollment 385
Est. completion date January 31, 2019
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender All
Age group 80 Years and older
Eligibility Inclusion Criteria:

- Patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches

Exclusion Criteria:

- Surgical resections for rectal cancer and surgical procedures for non-neoplastic colon pathologies

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Colon Surgery
Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert

Locations

Country Name City State
Italy Bruno Nardo Bologna
Italy Marialuisa Lugaresi Bologna

Sponsors (1)

Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary New surgical score using preoperative parameters to predict 30-day mortality after colon cancer surgery in the elderly population MEC Score (arterial saturation of O2, Systolic Blood Pressure, Heart Rate, WBCs, Albumin, Creatinine) for the evaluation of the risk of in-hospital mortality occurred during hospitalization up to 30 days Up to 30 days after surgery
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