Abdomen, AcuteNCT04176432
Survival After Emergency Laparotomy in Octogenarians
An observational study of Abdomen, Acute and Surgery--Complications, run by Haukeland University Hospital.
Trial summary
In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Abdomen, Acute, Surgery--Complications, Postoperative Complications
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Jan 2019
- 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 80 years and older
- All sexes
- Older adult
Study population: Patients admitted to Haukeland University Hospital during 2015-2016
Who may be able to join
- emergency laparotomy in patients 80 years or above
Who cannot join
- palliative surgery
- abdominal surgery other than gastrointestinal
- abdominal surgery without midline incision
About this study
Official title: Mortality and Complications After Emergency Laparotomy in Patients 80 Years Old or Older
In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above.
Read the detailed description
Methods:
During 2015-2016 106 patients aged 80 years or above underwent emergency laparotomy at Haukeland University Hospital.
Primary outcome was mortality at 30 days. Secondary outcomes were mortality at 90 days, 1 year, postoperative complications and level of care at discharge.
The Medical records were reviewed in detail and mortality and postoperative morbidity were registered. Post-operative complications were defined according to the European Perioperative Clinical Outcome (EPCO) definitions and included if they were Clavien Dindo grade 2 or above.
- Being tested
- No intervention
- Keywords
- Emergency surgery, Frailty, Elderly, Postoperative complications
- Medical subject headings
- Abdomen, Acute, Postoperative Complications, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Retrospective observational study with no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Deaths within 30 days after emergency laparotomy
Mortality at 30 days after date of emergency laparotomy
Measured: From date of emergency laparotomy until 30 days after surgery
Secondary outcomes (4)
Number of Deaths within 90 days after emergency laparotomy
Mortality at 90 days after date of emergency laparotomy
Measured: 90 days after emergency laparotomy
Number of Deaths within 1 year after emergency laparotomy
Mortality at 1 year after date of emergency laparotomy
Measured: 1 year after emergency laparotomy
Postoperative complications
Number of patients having a postoperative complication as defined by the European Perioperative Clinical Outcome Definitions (EPCO) will be reported. The EPCO definitions state universal description of various common postoperative complications, like f.ex pulmonary complications, major adverse cardiac events, urinary tract infections and so on. This is a way of securing a universal approach to postoperative complications.
We will grade complications according to the Clavien Dindo classification. According to this classification postoperative complications are graded from 1 to 5, where 1 indicates least severity of complication and 5 indicating worst severity. We will report number of patients having complications from grade 2 to grade 5.
Measured: Postoperative complications registered in medical records from date of emergency laparotomy until death in hospital or discharge from hospital, whichever came first.
Level of care at discharge
From the medical records will be retreived information regarding dependency in activities of daily living (ADL) at discharge. Specifically will be measured number of patients discharged to own home, and number of patients discharged to nursing home facility. Also will be measured number of patients transferred to other hospital.
Measured: Up to 90 days from date of emergency laparotomy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Jan 2015
- Primary completion31 Dec 2016
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdomen, AcuteStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176432
- Sponsor's protocol ID
- 2017/610
- Other IDs
- REK 9526
- Status last verified
- Nov 2019
- First submitted
- 27 Sep 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Complications After Emergency Laparotomy in Patients 80 Years Old or Older
- ClinicalTrials.gov ID
- NCT04176432
- Acronym / sponsor ID
- 2017/610
- Keywords
- Emergency surgery, Frailty, Elderly, Postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 25 Nov 2019 (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.
In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above.
Detailed description
Methods:
During 2015-2016 106 patients aged 80 years or above underwent emergency laparotomy at Haukeland University Hospital.
Primary outcome was mortality at 30 days. Secondary outcomes were mortality at 90 days, 1 year, postoperative complications and level of care at discharge.
The Medical records were reviewed in detail and mortality and postoperative morbidity were registered. Post-operative complications were defined according to the European Perioperative Clinical Outcome (EPCO) definitions and included if they were Clavien Dindo grade 2 or above.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients admitted to Haukeland University Hospital during 2015-2016
Key inclusion criteria (1 listed)
- emergency laparotomy in patients 80 years or above
Key exclusion criteria (3 listed)
- palliative surgery
- abdominal surgery other than gastrointestinal
- abdominal surgery without midline incision
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 |
|---|---|---|
| No interventionRetrospective observational study with no intervention | Other | – |
Primary outcome
Number of Deaths within 30 days after emergency laparotomy
Time frame: From date of emergency laparotomy until 30 days after surgery
Mortality at 30 days after date of emergency laparotomy
4 secondary outcomes
Number of Deaths within 90 days after emergency laparotomy
Time frame: 90 days after emergency laparotomy
Number of Deaths within 1 year after emergency laparotomy
Time frame: 1 year after emergency laparotomy
Postoperative complications
Time frame: Postoperative complications registered in medical records from date of emergency laparotomy until death in hospital or discharge from hospital, whichever came first.
Level of care at discharge
Time frame: Up to 90 days from date of emergency laparotomy.
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 25 Nov 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdomen, Acute and Surgery--Complications, run by Haukeland University Hospital.
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 3 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 25 Nov 2019. 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?
Number of Deaths within 30 days after emergency laparotomy (time frame: From date of emergency laparotomy until 30 days after surgery). 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 25 Nov 2019.