Multicenter National Trial of Clinical Results of Surgica... | NCT05254262

Studies
Multicenter National Trial of Clinical Results of Surgical Elderly Patients

NCT05254262

Sponsor

Germans Trias i Pujol Hospital

Status

Completed

Last Update Posted

Mar 13, 2025Actual

Enrollment

2,000Actual

Phase

Not provided

Conditions

Surgery--Complications
Age Problem

Interventions

Elderly surgical patients

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 31, 2023Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Feb 14, 2022

First Submission Date that Met QC Criteria

Feb 23, 2022

First Posted Date

Feb 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2025

Last Update Posted Date

Mar 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

David Parés MD, PhD, Professor of Surgery and Principal Investigator, Germans Trias i Pujol HospitalPrincipal Investigator

Lead Sponsor

Germans Trias i Pujol HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to study clinical results including mrobidity and mortality of elderly patients (age > 75 years) in Spain during a 3-month period.

Detailed Description

The aim of the study it is to analyze the morbidity and mortality of patients older tha 70 admitted on hospital and who needs surgical operation. The results will be analysed in relationship with surgical risk calculator in order to know if it would be posssible to predict morbi-mortality of these cohort of patirents.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Elderly patients		Patients age 70 or older, who are admitted in hospital for surgical operation (elective or emergency surgery)	Procedure: Elderly surgical patients

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Elderly surgical patients	Procedure	Patients who needs elective or emergency surgery for any reason	Elderly patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Patients death during hospitalization or first 30 days after surgery	30 day
Complications	Any complication during admission or 30 day after	30 day

Secondary Outcomes

Measure	Description	Time Frame
ASA score	Assessment of surgical risk	preoperative
ACS NSQIP surgical risk score	Assessment of surgical risk	preoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with an age of 70 years old or older
Admitted on hospital (minimum 1 day of hospital length)
Needing surgery

Exclusion Criteria:

Day case -surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

Elderly patients with and age of 70 years old or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Parés, MD, PhD	Department of Surgery, Hospital Germans Trias i Pujol	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidad de Murcia		Murcia			Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided