Morbimortality in Older Patients Undergoing Urgent Abdominal Surgery

March 22, 2020 updated by: Ines Eguaras, Hospital of Navarra

Analysis of Morbimortality and Functional Status in Older Patients(>65 Years Old) Undergoing Urgent Abdominal Surgery Using CRISTAL Score Modify

Morbimortality in older patients undergoing abdominal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to validate the modified CriSTAL tool for 30 mortality in elderly patients undergoing urgent abdominal surgery. To provide a new tool that could be used in conjunction with clinical judgment to aid in decision-making.

The second objective of our study was to assess the quality of life, frailty, functional status and nutritional status in elderly patients that survive six months after an urgent abdominal surgery.

Study Type

Observational

Enrollment (Actual)

500

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

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • UPNA

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

63 years to 108 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patiens>65 years old

Description

Inclusion Criteria:

  • >65 years old, accepted in emergency department

Exclusion Criteria:

  • not sign the 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
surgical management
Patient older than 65 years old, undergoing urgent abdominal surgery in our center
Procedure: surgery
not surgical management
Patients that presents a surgical disease, but we desestimate surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel index, questionnaire
Time Frame: 6 months
to measure performance in activities of daily living
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clavien- Dindo Modified
Time Frame: 1 year
Morbimortality using Clavien-Dindo classification
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
FRAIL scale, Fried score
Time Frame: 6 months
To measure frailty
6 months

Collaborators and Investigators

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

Sponsor

Hospital of Navarra

Investigators

  • Study Director: javier Herrera, doctor, UPNA

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)

January 1, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

June 29, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 22, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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