Abdomen, AcuteLAPTOPNCT05623176
Clinical Outcomes and Equality in Healthcare for Emergency General Surgery Patients Undergoing Emergency Laparotomy
An observational study of Abdomen, Acute, run by Region Stockholm at 1 site in Sweden.
Trial summary
The goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Abdomen, Acute
- What is being tested?
- Standardised laparotomy care
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2015to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inclusion of adult general surgical patients undergoing an emergency laparotomy during period 2015 and 2029. The cohort of 2015-2022 will be compared to the cohort of 2023-2029 in terms of general outcomes. The cohort of 2023-2029 will specifically be studied for any impact of emergency laparotomy on quality of life.
Who may be able to join
- Undergoing emergency laparotomy due to general surgical indication
Who cannot join
- Children under 16
- Trauma laparotomy
- Vascular, urological or gynaecological indication for laparotomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Rebecka Ahl Hulme, MD PhD, 0046812373212, rebecka.ahl-hulme@regionstockholm.se
Anna Ohlsson, MD PhD, anna.ohlsson@regionstockholm.se
About this study
Official title: Improvement in Patient Survival and Equality in Care Provision for General Surgery Patients Undergoing Emergency Laparotomy - Can This be Achieved Through the Implementation of Standardised Care Protocols?
The goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery.
The main questions it aims to answer are:
Read more
- what factors are associated with adverse post-operative events
- are patients treated differently based on sex or age
- how does quality of life look like and possibly change over the coarse of a year after surgery
This is an evaluation of the current standard of care and the outcomes of this patient group prior to the implementation of a standardised care protocols for emergency laparotomy patients. Secondly, the study aims to, over time, compare results before and after the introduction of this standardised care protocol.
- Conditions
- Abdomen, Acute
- Being tested
- Standardised laparotomy care
- Keywords
- Emergency laparotomy, General surgery, Clinical outcomes
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardised laparotomy careOther
This is a cohort study and no intervention as part of the study has been introduced. We are studying two groups and comparing the two before and after the introduction of a standardised laparotomy care protocol as part of a clinical quality improvement measure.
| Study group | Role | What they receive |
|---|---|---|
| Old routine of non-standardised laparotomy care | Group following the old routine of emergency laparotomy care i.e. no existing standardised care protocols. | |
| New routine of standardised laparotomy care | Group which has been part of the hospital's new standardised care routine for emergency laparotomy. Receives: Other: Standardised laparotomy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 30 days
Secondary outcomes (3)
In-hospital serious complications
Severity measured through Clavien-Dindo classification
Measured: 30 days
Long-term mortality
Measured: 1 year
Quality of life questionnaires
As measured through questionnaires at 1 month, 3 months and up to 1 year post-operatively.
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 posted21 Nov 2022
- Study start1 Jan 2015
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
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 Region StockholmThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rebecka Ahl Hulme, Region Stockholm
- Investigators
- Rebecka Ahl Hulme, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623176
- Sponsor's protocol ID
- K2022-9097
- Acronym
- LAPTOP
- Status last verified
- Dec 2024
- First submitted
- 12 Nov 2022
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Patient Survival and Equality in Care Provision for General Surgery Patients Undergoing Emergency Laparotomy - Can This be Achieved Through the Implementation of Standardised Care Protocols?
- ClinicalTrials.gov ID
- NCT05623176
- Acronym / sponsor ID
- LAPTOP / K2022-9097
- Conditions
- Abdomen, Acute
- Keywords
- Emergency laparotomy, General surgery, Clinical outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Nov 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 goal of this observational cohort study is to evaluate the standard of care for general surgerical patients undergoing emergency laparotomy and assess factors affecting clinical outcomes, as well as evaluating the quality of life in the year after abdominal surgery.
The main questions it aims to answer are:
- what factors are associated with adverse post-operative events
- are patients treated differently based on sex or age
- how does quality of life look like and possibly change over the coarse of a year after surgery
This is an evaluation of the current standard of care and the outcomes of this patient group prior to the implementation of a standardised care protocols for emergency laparotomy patients. Secondly, the study aims to, over time, compare results before and after the introduction of this standardised care protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Old routine of non-standardised laparotomy care | – | –Group following the old routine of emergency laparotomy care i.e. no existing standardised care protocols. |
| New routine of standardised laparotomy care | – | Other: Standardised laparotomy careGroup which has been part of the hospital's new standardised care routine for emergency laparotomy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inclusion of adult general surgical patients undergoing an emergency laparotomy during period 2015 and 2029. The cohort of 2015-2022 will be compared to the cohort of 2023-2029 in terms of general outcomes. The cohort of 2023-2029 will specifically be studied for any impact of emergency laparotomy on quality of life.
Key inclusion criteria (1 listed)
- Undergoing emergency laparotomy due to general surgical indication
Key exclusion criteria (3 listed)
- Children under 16
- Trauma laparotomy
- Vascular, urological or gynaecological indication for laparotomy
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 |
|---|---|---|
| Standardised laparotomy careThis is a cohort study and no intervention as part of the study has been introduced. We are studying two groups and comparing the two before and after the introduction of a standardised laparotomy care protocol as part of a clinical quality improvement measure. | Other | New routine of standardised laparotomy care |
Primary outcome
In-hospital mortality
Time frame: 30 days
3 secondary outcomes
In-hospital serious complications
Time frame: 30 days
Long-term mortality
Time frame: 1 year
Quality of life questionnaires
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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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.
Rebecka Ahl Hulme, MD PhD principal investigator
Karolinska University Hospital
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 Abdomen, Acute, run by Region Stockholm at 1 site in Sweden.
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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecka Ahl Hulme, MD PhD (0046812373212, rebecka.ahl-hulme@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: 30 days). 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 11 Dec 2024.