Surgery--ComplicationsNCT04725968
Morbimortality in Major Urgent General Surgery in the Geriatric Patient.
An observational study of Surgery--Complications and Emergencies, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018. Our principal goals are: 1. To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale) 2. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Surgery--Complications, Emergencies
- What is being tested?
- Urgent major general surgery
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 28 Jan 2021to 15 Mar 2021
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All the geriatric patients operated of urgent major general surgery in our centre during 2018.
Who may be able to join
- Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies
Who cannot join
- Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.
Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.
Our principal goals are:
- To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
- To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.
- Conditions
- Surgery--Complications, Emergencies
- Being tested
- Urgent major general surgery
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent major general surgeryProcedure or surgery
All geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications
Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale).
Measured: 30 days after surgery
Mortality rate
Global mortality and mortality after: 30 days, 6 months and 1 year.
Measured: 1 year
Secondary outcomes (4)
Days of admission
Measured: 30 days after surgery
days in ICU/Reanimation
Measured: 30 days after surgery
NELA Risk Score
"National Emergency Laparotomy Audit" % of death
Measured: pre-surgery
NSQUIP Risk Score
"American College of Surgeons National Surgical Quality Improvement Program": % of death
Measured: pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start28 Jan 2021
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
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.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725968
- Sponsor's protocol ID
- IIBSP-CGM-2020-108
- Status last verified
- Mar 2021
- First submitted
- 16 Jan 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.
- ClinicalTrials.gov ID
- NCT04725968
- Acronym / sponsor ID
- IIBSP-CGM-2020-108
- Conditions
- Surgery--Complications, Emergencies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 27 Jan 2021 (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.
Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.
Our principal goals are:
- To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
- To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All the geriatric patients operated of urgent major general surgery in our centre during 2018.
Key inclusion criteria (1 listed)
- Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies
Key exclusion criteria (1 listed)
- Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries
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 |
|---|---|---|
| Urgent major general surgeryAll geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre | Procedure or surgery | – |
Primary outcome
Incidence of complications
Time frame: 30 days after surgery
Evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale).
Mortality rate
Time frame: 1 year
Global mortality and mortality after: 30 days, 6 months and 1 year.
4 secondary outcomes
Days of admission
Time frame: 30 days after surgery
days in ICU/Reanimation
Time frame: 30 days after surgery
NELA Risk Score
Time frame: pre-surgery
NSQUIP Risk Score
Time frame: pre-surgery
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 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Emergencies, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau 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 2021. 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?
Incidence of complications (time frame: 30 days after surgery). 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 24 Mar 2021.