Inflammation Clinical Trial
— BAHAMASOfficial title:
Biomarkers in Acute High-risk AbdoMinAl Surgery
NCT number | NCT03582631 |
Other study ID # | BAHAMAS1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2013 |
Est. completion date | May 1, 2022 |
Verified date | August 2022 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Acute high-risk abdominal surgery (AHA) is performed in hospitals worldwide. Ethiologies are heterogeneous, but it carries a high mortality rate (1)(2). In particular, emergency laparotomies performed on elderly people has a high mortality rate(3)(4). Different quality improvement programs have been suggested, but the quality of care and mortality varies between hospitals (5)(6). The use of postoperative intensive care seem to be inadequate for this high risk population (1)(7)(8). It is of paramount importance to identify the frailest and acutely deranged patients, who are in risk of poor outcome, to allocate resources for optimization postoperatively. Failure to escalate care intensity after having developed postoperative complications affect outcome. Organization, teamwork and culture is important postoperatively to be able to escalate care especially in standard care wards (9)(10). However, it is difficult to predict which patients will develop complications. Different risk assessment tools have been proposed for patients undergoing AHA (11)(12). The APACHE-II score, even though developed for critical care, seems to give the best prediction of outcome. Objective risk assessment tools support clinical decision making as subjective clinical assessment often underestimates the risk for the patients in highest risk of complications and death (13). Good clinical decision-making is likely to improve the clinical outcome by allocating appropriate resources. Prognostic tools are also useful to inform patients about what to expect in the postoperative phase and of long-term outcome. Especially in the elder population with increased risk of loss of function or independency, this can be useful to give informed consent to treatment. Furthermore, good risk assessment is important to optimize palliative care after end-of-life decisions, which is often ignored in research, but highly relevant in clinical work. Prognostic biomarkers in other high mortality populations have received much attention for risk stratification (14). An ideal biomarker should be readily available upon decision-making, easy to measure, and reliable. Furthermore, it should accurately differentiate prognosis for patients to have value in the clinical decision-making and guide the treatment. It should also be linked to the clinical outcomes. The investigators aim to identify AHA biomarkers that are prognostic or predictive for postoperative morbidity, mortality and length of hospitalization.
Status | Completed |
Enrollment | 600 |
Est. completion date | May 1, 2022 |
Est. primary completion date | May 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged 18 or older with the suspicion for abdominal pathology requiring immediate emergency laparotomy or laparoscopy including reoperations after elective surgery and reoperations after previous AHA surgery. Exclusion Criteria: - We excluded the following procedures: appendectomies; negative laparoscopies and laparotomies; cholecystectomies; simple herniotomies following incarceration (without intestinal resection); reoperation due to fascial separation with no other abdominal pathology; internal herniation after roux-en-y gastric bypass surgery; sub-acute surgery (planned within 48 hours) for inflammatory bowel disease; and sub-acute colorectal cancer surgery. We excluded, traumas, pregnant woman, uro-genital, gynaecological and vascular pathology except for mesenteric ischemia. |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre University hospital | Hvidovre | Capital Region |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Hvidovre University Hospital |
Denmark,
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* Note: There are 32 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | No of patients died within 30 days postoperatively | 30 day mortality after surgery | 30 days | |
Primary | No of patients died within 180 days postoperatively | 180-day mortality after surgery | 180 days | |
Primary | No of patients with major postoperative complications within 30 days afer surgery | Clavien Dindo grade more than 3a | 30 days |
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