Surgery--ComplicationsNCT03205384
Morbimortality in Older Patients Undergoing Urgent Abdominal Surgery
An observational study of Surgery--Complications, run by Hospital of Navarra at 1 site in Spain.
Trial summary
Morbimortality in older patients undergoing abdominal surgery. Read more about this study
- Who is it for?
- Ages 65 to 110 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Jun 2019
- How long will I take part?
- 2 Years
- 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 65 to 110 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: patiens>65 years old
Who may be able to join
- >65 years old, accepted in emergency department
Who cannot join
- not sign the consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Morbimortality and Functional Status in Older Patients(>65 Years Old) Undergoing Urgent Abdominal Surgery Using CRISTAL Score Modify
Morbimortality in older patients undergoing abdominal surgery.
Read the detailed description
The aim of this study is to validate the modified CriSTAL tool for 30 mortality in elderly patients undergoing urgent abdominal surgery. To provide a new tool that could be used in conjunction with clinical judgment to aid in decision-making.
The second objective of our study was to assess the quality of life, frailty, functional status and nutritional status in elderly patients that survive six months after an urgent abdominal surgery.
- Conditions
- Surgery--Complications
- Being tested
- surgery
- Keywords
- Urgent abdominal surgery. Quality of life, functional status, frailty, nutritional status
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| surgical management | Patient older than 65 years old, undergoing urgent abdominal surgery in our center Receives: Procedure: surgery | |
| not surgical management | Patients that presents a surgical disease, but we desestimate surgical procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel index, questionnaire
to measure performance in activities of daily living
Measured: 6 months
Secondary outcomes (1)
Clavien- Dindo Modified
Morbimortality using Clavien-Dindo classification
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study startJan 2017
- Primary completionJun 2019
- Study completionJun 2019
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
- 500 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Eguaras, Hospital of Navarra
- Investigators
- javier Herrera, doctor, Study director, UPNA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205384
- Sponsor's protocol ID
- CHN
- Status last verified
- Mar 2020
- First submitted
- 22 Feb 2017
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Morbimortality and Functional Status in Older Patients(>65 Years Old) Undergoing Urgent Abdominal Surgery Using CRISTAL Score Modify
- ClinicalTrials.gov ID
- NCT03205384
- Acronym / sponsor ID
- CHN
- Conditions
- Surgery--Complications
- Keywords
- Urgent abdominal surgery. Quality of life, functional status, frailty, nutritional status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 2 Jul 2017 (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.
Morbimortality in older patients undergoing abdominal surgery.
Detailed description
The aim of this study is to validate the modified CriSTAL tool for 30 mortality in elderly patients undergoing urgent abdominal surgery. To provide a new tool that could be used in conjunction with clinical judgment to aid in decision-making.
The second objective of our study was to assess the quality of life, frailty, functional status and nutritional status in elderly patients that survive six months after an urgent abdominal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical management | – | Procedure: surgeryPatient older than 65 years old, undergoing urgent abdominal surgery in our center |
| not surgical management | – | –Patients that presents a surgical disease, but we desestimate surgical procedure |
Who may qualify
- Ages
- 65 to 110 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- patiens>65 years old
Key inclusion criteria (1 listed)
- >65 years old, accepted in emergency department
Key exclusion criteria (1 listed)
- not sign the consent
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 |
|---|---|---|
| surgery | Procedure or surgery | surgical management |
Primary outcome
Barthel index, questionnaire
Time frame: 6 months
to measure performance in activities of daily living
1 secondary outcome
Clavien- Dindo Modified
Time frame: 1 year
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 24 Mar 2020.
- 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.
javier Herrera, doctor study director
UPNA
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, run by Hospital of Navarra 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 1 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 24 Mar 2020. 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?
Barthel index, questionnaire (time frame: 6 months). 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 24 Mar 2020.