Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Study Overview
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Brief Summary
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In the ProPEL study the effect of a protocol designed for elderly patients about to undergo emergency abdominal surgery will be investigated. The protocol addresses issues of both frailty and ceiling-of -care decisions.

Detailed Description
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In the ProPEL study, investigators will test the effect of a care bundle designed for patients aged ≥75 years undergoing emergency laparotomy/laparoscopy. An interdisciplinary team of anesthetists, intensivists, surgeons, and geriatricians developed the care bundle, and the essential elements are frailty scoring, surveillance and optimization of patients, surgical treatment within predefined criteria, and postoperative delirium monitoring. Preoperatively, patients with abdominal pathology requiring emergency surgery will be evaluated for frailty by the surgical team, using standardized frailty scores. Palliative care could be an alternative to surgery in very frail patients. The decision to not perform surgery is a clinical decision made with the patient and/or relatives in a shared decision-making process. Frailty scoring can assist in this procedure. The effect of the care-bundle will be compared to a historical cohort, using 30-day mortality as the primary outcome.

Official Title
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Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Conditions
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Frailty, Surgery--Complications, Outcome, Fatal, Frail Elderly Syndrome, Post-Op Complication, Gastro-Intestinal Disorder

Intervention / Treatment
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* Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patients above 75 years with clinical suspicion of abdominal condition requiring surgery Exclusion Criteria: Former inclusion in ProPEL Surgery for incarcerated hernia without laparotomy Appendectomy without laparotomy Palliative surgery for already known inoperable gastrointestinal tumor Palliation without surgical treatment Vascular surgery

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated, and the results will be compared to a group of historical controls operated at Haukeland University Hospital in 2016-2017, using 30-day mortality as the primary outcome.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care bundle<br>Patients above 75 years where emergency surgery is indicated, deemed fit for surgery, will be included in a perioperative care-bundle. While waiting for surgery, patients will be monitored and optimized if their condition deteriorates. Antibiotics will be administered if indicated. Surgery will be delivered within 2h to 72h, depending on the suspected abdominal pathology and the patient's clinical condition. | Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy<br>* See above section<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | Number of deaths within 30 days after emergency abdominal surgery | Up to 30 days after the performance of emergency abdominal surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Thus, postoperative complications are reported in a uniform way. 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. | up to 90 days after date of emergency surgery | 
| Frequency of post-operative delirium | Number of patients having postoperative delirium as defined by the screening tool 4 AT. On this 4-item screening tool for delirium patients are scored from 0 (minimum) up to 12 points (maximum). Screening for delirium is positive if score is 4 or above. | up to 30 days after emergency surgery | 
| Length of stay in hospital after EAS | Number of days spent in hospital after EAS | up to 90 days after emergency surgery | 
| Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after surgery | Activity of Daily Living (ADL) is measured using the Barthel ADL-index (Norwegian Version), a validated 10-item questionnaire. In this scale the patients level of functioning is described and assigned from 0 to 20 points. Zero points indicate total dependency and 20 points indicate Complete independency in Activities of Daily Living. | Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal surgery. | 
| Level of care at discharge from hospital and one year after EAS | Number of patients discharged to own home after EAS. Number of patients discharged to nursing home after EAS. Number of patients living in own home or in nursing home one year after EAS. | 1 year after EAS. | 
| 1-year mortality | Number of deaths within 1 year after emergency abdominal surgery (EAS) | From time of EAS performed and up to 1 year | 
| Days at home in first postoperative year | Number of days living in own home first year after EAS | From date of discharge from hospital after EAS and up to one year postoperatively | 
| Readmissions after EAS | Number of patients readmitted to hospital after first being discharged from hospital after EAS | From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge. | 
| Patient Reported Outcome Measures (PROM)one year after EAS | Patients report on own Health performance as measured by the 36-Item Short Form Survey. In this survey patients subjective health status is described using 36 standardized questions. Patients will also be asked about their willingness to undergo same procedure again, if indicated. | One year after procedure performed (EAS). | 
| 5-year survival | Number of Deaths occurring within 5 years after EAS | From inclusion in study and up to five years after EAS. |