- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05254262
Multicenter National Trial of Clinical Results of Surgical Elderly Patients (CiruGerES:)
March 11, 2025 updated by: David Parés MD, PhD, Germans Trias i Pujol Hospital
An Observational Multicenter National Trial of Clinical Results and Morbimortality of Surgical Elderly Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
2000
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
-
-
-
Murcia, Spain
- Universidad de Murcia
-
-
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
70 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Elderly patients with and age of 70 years old or older
Description
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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Elderly patients
Patients age 70 or older, who are admitted in hospital for surgical operation (elective or emergency surgery)
|
Patients who needs elective or emergency surgery for any reason
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 30 day
|
Patients death during hospitalization or first 30 days after surgery
|
30 day
|
|
Complications
Time Frame: 30 day
|
Any complication during admission or 30 day after
|
30 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ASA score
Time Frame: preoperative
|
Assessment of surgical risk
|
preoperative
|
|
ACS NSQIP surgical risk score
Time Frame: preoperative
|
Assessment of surgical risk
|
preoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Parés, MD, PhD, Department of Surgery, Hospital Germans Trias i Pujol
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)
September 1, 2022
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
February 14, 2022
First Submitted That Met QC Criteria
February 23, 2022
First Posted (Actual)
February 24, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- CiruGerES-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
Clinical Trials on Surgery--Complications
-
Duke UniversityWithdrawnSurgical Complications From Surgery | Surgical Complications From Bladder Surgery | Surgical Complications From Bowel Surgery
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
-
Karolinska InstitutetRecruitingSurgery | Anesthesia | Surgery ComplicationsSweden
-
University of KwaZuluMedical Research Council, South AfricaCompletedMortality | Surgery | Surgery- ComplicationsSouth Africa, Algeria, Benin, Burundi, Cameroon, Congo, The Democratic Republic of the, Congo, Egypt, Ethiopia, Gambia, Ghana, Kenya, Libyan Arab Jamahiriya, Madagascar, Mali, Mauritius, Namibia, Nigeria, Niger, Senegal, Tanzania, Tog... and more
-
Baylor Research InstituteChiesi USA, Inc.CompletedSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Western University, CanadaNot yet recruitingSurgery | Surgery--Complications | Pulmonary Complication
-
Faiza GabaQueen Mary University of London; University of Hertfordshire; University of Aberdeen and other collaboratorsRecruitingGynecologic Cancer | Surgery | Surgery--ComplicationsUnited Kingdom
-
Hacettepe UniversityCompletedSurgery--Complications | Newborn Morbidity | Neonatal SurgeryTurkey
-
Vrinnevi HospitalActive, not recruitingRevisional Bariatric Surgery | Gastric Bypass Surgery | Complications After Bariatric SurgerySweden
-
Washington University School of MedicineNational Institute of Nursing Research (NINR)CompletedSurgery | Surgery--Complications | Perioperative/Postoperative ComplicationsUnited States
Clinical Trials on Elderly surgical patients
-
Adiyaman University Research HospitalCompletedGeriatric DisorderTurkey
-
Institut BergoniéEuropean Organisation for Research and Treatment of Cancer - EORTC; International...Completed
-
Azienda Ospedaliera San Giovanni BattistaCompleted
-
Centre Hospitalier Universitaire, AmiensCompletedGeriatric | VenipunctureFrance
-
Lili JiaShanxi Province Cancer Hospital; The First Affiliated Hospital of Shanxi Medical... and other collaboratorsCompletedPostoperative Complications | Respiratory Insufficiency | Ventilator WeaningChina
-
Beijing Friendship HospitalNot yet recruitingPostoperative Delirium | Preoperative Anxiety | Inflammatory Reaction | Preoperative Sleep Disorder
-
University of Medicine and Pharmacy at Ho Chi Minh...UnknownIncidence of Delirium in Inpatient Elderly PatientsVietnam
-
Hospices Civils de LyonCompletedResuscitationFrance, Mayotte
-
University Hospital, Clermont-FerrandAssistance Publique Hopitaux De MarseilleUnknown
-
Istanbul University - CerrahpasaCompleted