- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725968
Morbimortality in Major Urgent General Surgery in the Geriatric Patient.
March 22, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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:
- To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
- To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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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