An interventional study of Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy in Frailty, Surgery--Complications and Outcome, Fatal, sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Haukeland University Hospital · Not applicable, Interventional, and Health services research
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.
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.
1,229 studies on the registry are indexed under Frailty; 433 are open to participants now.
This study's enrollment of 156 is above the median of 80 across 704 interventional studies indexed under Frailty.
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- Patients above 75 years with clinical suspicion of abdominal condition requiring surgery
Exclusion Criteria:
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
See above section
Composite score of 30-day mortality and postoperative complications
Composite score will be calculated using the Comprehensive Complication Index ranging from 0 points (uneventful postoperative recovery) to 100 points (postoperative death). One investigator will review the patient's medical record postoperatively to investigate if any medical complication has occurred. Complications are defined according to the EPCO definitions and graded according to the Clavien-Dindo classification system.
Time frame: Up to 30 days after the performance of emergency abdominal surgery
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.
Time frame: 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.
Time frame: up to 30 days after emergency surgery
Length of stay in hospital after EAS
Number of days spent in hospital after EAS
Time frame: 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.
Time frame: 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.
Time frame: 1 year after EAS.
1-year mortality
Number of deaths within 1 year after emergency abdominal surgery (EAS)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: One year after procedure performed (EAS).
5-year survival
Number of Deaths occurring within 5 years after EAS
Time frame: From inclusion in study and up to five years after EAS.
30-day mortality in all patients with indication to undergo surgery
30-day mortality rate in palliative and operated patients
Time frame: Time (days) up to 30 days after treatment decision (palliation or surgery) is made
3-year survival
Number of deaths occuring within 3 years after EAS
Time frame: Time (days) from end of index surgery and up to 3 years after EAS.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Jun 2021, 17 months.
Of 477 non-industry interventional studies with no phase under Frailty, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 17 months is below that.
Counting every sponsor, half of 484 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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