Morbimortality in Major Urgent General Surgery in the Geriatric Patient.

Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.

Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.

Our principal goals are:

  1. To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
  2. To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

120

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

      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All the geriatric patients operated of urgent major general surgery in our centre during 2018.

Description

Inclusion Criteria:

  • Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies

Exclusion Criteria:

  • Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: 30 days after surgery
Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale).
30 days after surgery
Mortality rate
Time Frame: 1 year
Global mortality and mortality after: 30 days, 6 months and 1 year.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days of admission
Time Frame: 30 days after surgery
30 days after surgery
days in ICU/Reanimation
Time Frame: 30 days after surgery
30 days after surgery
NELA Risk Score
Time Frame: pre-surgery
"National Emergency Laparotomy Audit" % of death
pre-surgery
NSQUIP Risk Score
Time Frame: pre-surgery
"American College of Surgeons National Surgical Quality Improvement Program": % of death
pre-surgery

Collaborators and Investigators

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

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 28, 2021

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

January 16, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-CGM-2020-108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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