CiruGerES:: Multicenter National Trial of Clinical Results of Surgical Elderly Patients

Sponsor
Germans Trias i Pujol Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05254262
Collaborator
(none)
2,000
1
3
669

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Elderly surgical patients

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
An Observational Multicenter National Trial of Clinical Results and Morbimortality of Surgical Elderly Patients
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Elderly patients

Patients age 70 or older, who are admitted in hospital for surgical operation (elective or emergency surgery)

Procedure: Elderly surgical patients
Patients who needs elective or emergency surgery for any reason

Outcome Measures

Primary Outcome Measures

  1. Mortality [30 day]

    Patients death during hospitalization or first 30 days after surgery

  2. Complications [30 day]

    Any complication during admission or 30 day after

Secondary Outcome Measures

  1. ASA score [preoperative]

    Assessment of surgical risk

  2. ACS NSQIP surgical risk score [preoperative]

    Assessment of surgical risk

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad de Murcia Murcia Spain

Sponsors and Collaborators

  • Germans Trias i Pujol Hospital

Investigators

  • Principal Investigator: David Parés, MD, PhD, Department of Surgery, Hospital Germans Trias i Pujol

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Parés MD, PhD, Professor of Surgery and Principal Investigator, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT05254262
Other Study ID Numbers:
  • CiruGerES-1
First Posted:
Feb 24, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 18, 2022