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NCT04725968 Clinical Trial

Morbimortality in Major Urgent General Surgery in the Geriatric Patient.

Emergencies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04725968
Other study ID # IIBSP-CGM-2020-108
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 28, 2021
Est. completion date March 15, 2021

Study information
Verified date March 2021
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 15, 2021
Est. primary completion date March 15, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Urgent major general surgery
All geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre

Locations
Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of complications Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale). 30 days after surgery
Primary Mortality rate Global mortality and mortality after: 30 days, 6 months and 1 year. 1 year
Secondary Days of admission 30 days after surgery
Secondary days in ICU/Reanimation 30 days after surgery
Secondary NELA Risk Score "National Emergency Laparotomy Audit" % of death pre-surgery
Secondary NSQUIP Risk Score "American College of Surgeons National Surgical Quality Improvement Program": % of death pre-surgery
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