- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293653
Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy ((ProPEL))
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway, 5021
- Haukeland University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Care bundle
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.
|
See above section
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day mortality
Time Frame: Up to 30 days after the performance of emergency abdominal surgery
|
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
Time Frame: up to 90 days after date of emergency surgery
|
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
Time Frame: up to 30 days after emergency surgery
|
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
Time Frame: up to 90 days after emergency surgery
|
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
Time Frame: Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal 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
Time Frame: 1 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
Time Frame: From time of EAS performed and up to 1 year
|
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
Time Frame: From date of discharge from hospital after EAS and up to one year postoperatively
|
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
Time Frame: From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge.
|
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
Time Frame: One year after procedure performed (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
Time Frame: From inclusion in study and up to five years after EAS.
|
Number of Deaths occurring within 5 years after EAS
|
From inclusion in study and up to five years after EAS.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ib Jammer, MD, PhD
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK7110
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frail Elderly Syndrome
-
DSM Nutritional Products, Inc.CompletedFrail Elderly | Pre-frail ElderlyNetherlands
-
McMaster UniversityAlberta Health services; Saskatchewan Health Authority - Regina Area; Canadian... and other collaboratorsActive, not recruitingFrail Elderly SyndromeCanada
-
Università degli Studi del Piemonte Orientale "Amedeo...Completed
-
University of Massachusetts, WorcesterAnesthesia Patient Safety FoundationCompleted
-
School of Health Sciences GenevaInstitution genevoise de maintien à domicileCompletedFrail Elderly Syndrome
-
University of GlasgowNHS Greater Glasgow and ClydeUnknownFrail Elderly SyndromeUnited Kingdom
-
Castilla-La Mancha Health ServiceColegio Oficial de Terapeutas Ocupacionales de Castilla - La Mancha; Fundación... and other collaboratorsRecruiting
-
Federico II UniversityRecruiting
-
Guang Yang, Prof. Dr.CompletedFrail Elderly SyndromeChina
Clinical Trials on Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy
-
The Christie NHS Foundation TrustRecruiting