Mortality Score in Elderly Patients With Colon Cancer | NCT04538404

Studies
Mortality Score in Elderly Patients With Colon Cancer

NCT04538404

Sponsor

University of Bologna

Status

Completed

Last Update Posted

Sep 4, 2020Actual

Enrollment

385Actual

Phase

Not provided

Conditions

Mortality
Surgery
Colon Cancer

Interventions

Colon Surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2011Actual

Primary Completion Date

Aug 31, 2017Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Aug 22, 2020

First Submission Date that Met QC Criteria

Sep 3, 2020

First Posted Date

Sep 4, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2020

Last Update Posted Date

Sep 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

385Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colon Surgery	Procedure	Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Men and women patients aged 80 and above having elective and emergency colonic resection for colon cancer via open, laparoscopic and converted approaches.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Nardo, MD,PhD	University of Bologna	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bruno Nardo		Bologna		40138	Italy
Marialuisa Lugaresi

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided