Surgery--ComplicationsCiruGerES:NCT05254262
Multicenter National Trial of Clinical Results of Surgical Elderly Patients
An observational study of Surgery--Complications and Age Problem, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Surgery--Complications, Age Problem
- What is being tested?
- Elderly surgical patients
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 31 Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients with and age of 70 years old or older
Who may be able to join
- Patients with an age of 70 years old or older
- Admitted on hospital (minimum 1 day of hospital length)
- Needing surgery
Who cannot join
- Day case -surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgery--Complications, Age Problem
- Being tested
- Elderly surgical patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elderly surgical patientsProcedure or surgery
Patients who needs elective or emergency surgery for any reason
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients | Patients age 70 or older, who are admitted in hospital for surgical operation (elective or emergency surgery) Receives: Procedure: Elderly surgical patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patients death during hospitalization or first 30 days after surgery
Measured: 30 day
Complications
Any complication during admission or 30 day after
Measured: 30 day
Secondary outcomes (2)
ASA score
Assessment of surgical risk
Measured: preoperative
ACS NSQIP surgical risk score
Assessment of surgical risk
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Parés MD, PhD, Germans Trias i Pujol Hospital
- Investigators
- David Parés, MD, PhD, Principal investigator, Department of Surgery, Hospital Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254262
- Sponsor's protocol ID
- CiruGerES-1
- Acronym
- CiruGerES:
- Status last verified
- Feb 2023
- First submitted
- 14 Feb 2022
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multicenter National Trial of Clinical Results and Morbimortality of Surgical Elderly Patients
- ClinicalTrials.gov ID
- NCT05254262
- Acronym / sponsor ID
- CiruGerES: / CiruGerES-1
- Conditions
- Surgery--Complications, Age Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients | – | Procedure: Elderly surgical patientsPatients age 70 or older, who are admitted in hospital for surgical operation (elective or emergency surgery) |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients with and age of 70 years old or older
Key inclusion criteria (3 listed)
- Patients with an age of 70 years old or older
- Admitted on hospital (minimum 1 day of hospital length)
- Needing surgery
Key exclusion criteria (1 listed)
- Day case -surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elderly surgical patientsPatients who needs elective or emergency surgery for any reason | Procedure or surgery | Elderly patients |
Primary outcome
Mortality
Time frame: 30 day
Patients death during hospitalization or first 30 days after surgery
Complications
Time frame: 30 day
Any complication during admission or 30 day after
2 secondary outcomes
ASA score
Time frame: preoperative
ACS NSQIP surgical risk score
Time frame: preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Parés, MD, PhD principal investigator
Department of Surgery, Hospital Germans Trias i Pujol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications and Age Problem, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.