PERIPHERAL VASCULAR DISEASESNCT00672698
Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery
An observational study of PERIPHERAL VASCULAR DISEASES and Digestive Diseases, run by Cirujanos la Serena at 1 site in Chile.
Trial summary
The purpose of this study is to establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- PERIPHERAL VASCULAR DISEASES, Digestive Diseases, BILIARY TRACT DISEASES
- What is being tested?
- SURGERY
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteChile
- Study dates
- Nov 2008to Nov 2008
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients older than 65 years of age submitted to elective surgery at our institution
Who may be able to join
- Patients older than 65 years of age
- All necessary data to calculate p-possum and saps II
Who cannot join
- Patients with incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery: Comparative Study of Elective Vascular, Digestive and Biliary Surgery
The purpose of this study is to establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution.
- Being tested
- SURGERY
- Keywords
- SURGICAL RISK, ELDERLY, MAJOR SURGERY, P-POSSUM, SAPS II
- Medical subject headings
- Peripheral Vascular Diseases, Digestive System Diseases, Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGERYProcedure or surgery
ELECTIVE SURGICAL PROCEDURES
| Study group | Role | What they receive |
|---|---|---|
| I | VASCULAR SURGERY Receives: Procedure: SURGERY | |
| II | DIGESTIVE SURGERY Receives: Procedure: SURGERY | |
| III | BILIARY TRACT SURGERY Receives: Procedure: SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 YEAR
Secondary outcomes (1)
Morbidity
Measured: 1 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: NOT ENOUGH DATA AVAILABLE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PERIPHERAL VASCULAR DISEASESStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO A. BELTRAN, M.D., Cirujanos la Serena
- Investigators
- Marceloa A Beltran, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00672698
- Sponsor's protocol ID
- 15042008/001
- Status last verified
- Oct 2012
- First submitted
- 2 May 2008
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery: Comparative Study of Elective Vascular, Digestive and Biliary Surgery
- ClinicalTrials.gov ID
- NCT00672698
- Acronym / sponsor ID
- 15042008/001
- Keywords
- SURGICAL RISK, ELDERLY, MAJOR SURGERY, P-POSSUM, SAPS II
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: NOT ENOUGH DATA AVAILABLE
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 6 May 2008 (estimated)
- 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 purpose of this study is to establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I | – | Procedure: SURGERYVASCULAR SURGERY |
| II | – | Procedure: SURGERYDIGESTIVE SURGERY |
| III | – | Procedure: SURGERYBILIARY TRACT SURGERY |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients older than 65 years of age submitted to elective surgery at our institution
Key inclusion criteria (2 listed)
- Patients older than 65 years of age
- All necessary data to calculate p-possum and saps II
Key exclusion criteria (1 listed)
- Patients with incomplete data
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 |
|---|---|---|
| SURGERYELECTIVE SURGICAL PROCEDURES | Procedure or surgery | I, II, III |
Primary outcome
Mortality
Time frame: 1 YEAR
1 secondary outcome
Morbidity
Time frame: 1 MONTH
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
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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.
Marceloa A Beltran, M.D. principal investigator
Hospital de La Serena
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 PERIPHERAL VASCULAR DISEASES and Digestive Diseases, run by Cirujanos la Serena at 1 site in Chile.
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 2 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: withdrawn, as of the sponsor's last update on 31 Oct 2012. 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 Chile. 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 was withdrawn before enrolling participants, so there are no results.
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: 1 YEAR). 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 31 Oct 2012; AzTrials last refreshed its copy on 7 Nov 2026.