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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standardised laparotomy care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital mortality | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| In-hospital serious complications | Severity measured through Clavien-Dindo classification | 30 days |
| Long-term mortality | 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecka Ahl Hulme, MD PhD | Contact | 0046812373212 | rebecka.ahl-hulme@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Rebecka Ahl Hulme, MD PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
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| ID | Term |
|---|---|
| D000006 | Abdomen, Acute |
| ID | Term |
|---|---|
| D015746 | Abdominal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| Quality of life questionnaires |
As measured through questionnaires at 1 month, 3 months and up to 1 year post-operatively. |
| 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |