NCT04725968

Brief Summary

Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018. Our principal goals are:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 28, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

January 16, 2021

Last Update Submit

March 22, 2021

Conditions

Surgery--ComplicationsEmergencies

Outcome Measures

Primary Outcomes (2)

  • Incidence of complications

    Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale).

    30 days after surgery

  • Mortality rate

    Global mortality and mortality after: 30 days, 6 months and 1 year.

    1 year

Secondary Outcomes (4)

  • Days of admission

    30 days after surgery

  • days in ICU/Reanimation

    30 days after surgery

  • NELA Risk Score

    pre-surgery

  • NSQUIP Risk Score

    pre-surgery

Interventions

Urgent major general surgeryPROCEDURE

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 27, 2021

Study Start

January 28, 2021

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations

ES(1)