Emergency General SurgeryNCT05664360
Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery
An observational study of Emergency General Surgery, run by University Hospital, Geneva.
Trial summary
The objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emergency General Surgery
- What is being tested?
- Age (young versus older)
- How many people
- 310,914 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 15 Mar 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the emergency department
Who may be able to join
- consecutive patients visiting the emergency department
Who cannot join
- admitted primarily for a psychiatric reason
- left without consultation
About this study
The objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.
- Conditions
- Emergency General Surgery
- Being tested
- Age (young versus older)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age (young versus older)Other
Age
| Study group | Role | What they receive |
|---|---|---|
| ED patients | Not described Receives: Other: Age (young versus older) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of emergency general surgery
Emergency general surgery following ED visit
Measured: Day 3
Secondary outcomes (7)
Admission to intensive care unit rate
Admission to intensive care unit
Measured: During index hospitalization
ICU length of stay
Number of days spent in the ICU during hospital stay
Measured: During index hospitalization
30-day mortality rate
30-day mortality
Measured: 30 days
90-day mortality rate
90-day mortality
Measured: 90 days
One-year mortality rate
One-year mortality
Measured: One year
Hospital length of stay
Hospital length of stay
Measured: During index hospitalization
Rate of patient dependent at discharge
Dependent at discharge
Measured: Hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jan 2015
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency General SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- 310,914 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Fehlmann, University Hospital, Geneva
- Investigators
- Christophe A Fehlmann, MD, Principal investigator, Genava University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05664360
- Sponsor's protocol ID
- EGS1
- Status last verified
- Dec 2022
- First submitted
- 9 Dec 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery
- ClinicalTrials.gov ID
- NCT05664360
- Acronym / sponsor ID
- EGS1
- Conditions
- Emergency General Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310,914 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 23 Dec 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 objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ED patients | – | Other: Age (young versus older) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the emergency department
Key inclusion criteria (1 listed)
- consecutive patients visiting the emergency department
Key exclusion criteria (2 listed)
- admitted primarily for a psychiatric reason
- left without consultation
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 |
|---|---|---|
| Age (young versus older)Age | Other | ED patients |
Primary outcome
Incidence of emergency general surgery
Time frame: Day 3
Emergency general surgery following ED visit
7 secondary outcomes
Admission to intensive care unit rate
Time frame: During index hospitalization
ICU length of stay
Time frame: During index hospitalization
30-day mortality rate
Time frame: 30 days
90-day mortality rate
Time frame: 90 days
One-year mortality rate
Time frame: One year
Hospital length of stay
Time frame: During index hospitalization
Rate of patient dependent at discharge
Time frame: Hospital discharge
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 23 Dec 2022.
- Individual participant dataSharing planned: Yes
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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.
Christophe A Fehlmann, MD principal investigator
Genava University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency General Surgery, run by University Hospital, Geneva.
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 2 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 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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 emergency general surgery (time frame: Day 3). 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 23 Dec 2022.