Morbimortality in Major Urgent General Surgery in the Geriatric Patient.
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Completed
CT.gov ID
NCT04725968
Collaborator
(none)
120
1
1.5
79.4
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
120 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.
Actual Study Start Date
:
Jan 28, 2021
Actual Primary Completion Date
:
Mar 15, 2021
Actual Study Completion Date
:
Mar 15, 2021
Outcome Measures
Primary Outcome Measures
- Incidence of complications [30 days after surgery]
Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale).
- Mortality rate [1 year]
Global mortality and mortality after: 30 days, 6 months and 1 year.
Secondary Outcome Measures
- Days of admission [30 days after surgery]
- days in ICU/Reanimation [30 days after surgery]
- NELA Risk Score [pre-surgery]
"National Emergency Laparotomy Audit" % of death
- NSQUIP Risk Score [pre-surgery]
"American College of Surgeons National Surgical Quality Improvement Program": % of death
Eligibility Criteria
Criteria
Ages Eligible for Study:
75 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
Sponsors and Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT04725968
Other Study ID Numbers:
- IIBSP-CGM-2020-108
First Posted:
Jan 27, 2021
Last Update Posted:
Mar 24, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: