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Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy ((ProPEL))

Primary Purpose

Frailty, Surgery--Complications, Outcome, Fatal

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Frailty

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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 gastrointestinal tumour already known at time of inclusion
  • Palliation without surgical treatment
  • Vascular surgery

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Care bundle

Arm Description

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.

Outcomes

Primary Outcome Measures

30-day mortality
Number of deaths within 30 days after emergency abdominal surgery

Secondary Outcome Measures

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.
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.
Length of stay in hospital after EAS
Number of days spent in hospital after EAS
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.
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 mortality
Number of deaths within 1 year after emergency abdominal surgery (EAS)
Days at home in first postoperative year
Number of days living in own home first year after EAS
Readmissions after EAS
Number of patients readmitted to hospital after first being discharged from hospital after EAS
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.
5-year survival
Number of Deaths occurring within 5 years after EAS

Full Information

First Posted
January 2, 2020
Last Updated
August 16, 2023
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04293653
Brief Title
Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
Acronym
(ProPEL)
Official Title
Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frailty, Surgery--Complications, Outcome, Fatal, Frail Elderly Syndrome, Post-Op Complication, Gastro-Intestinal Disorder

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care bundle
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy
Intervention Description
See above section
Primary Outcome Measure Information:
Title
30-day mortality
Description
Number of deaths within 30 days after emergency abdominal surgery
Time Frame
Up to 30 days after the performance of emergency abdominal surgery
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
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
Title
Frequency of post-operative delirium
Description
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
Title
Length of stay in hospital after EAS
Description
Number of days spent in hospital after EAS
Time Frame
up to 90 days after emergency surgery
Title
Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after surgery
Description
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.
Title
Level of care at discharge from hospital and one year after EAS
Description
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.
Title
1-year mortality
Description
Number of deaths within 1 year after emergency abdominal surgery (EAS)
Time Frame
From time of EAS performed and up to 1 year
Title
Days at home in first postoperative year
Description
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
Title
Readmissions after EAS
Description
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.
Title
Patient Reported Outcome Measures (PROM)one year after EAS
Description
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).
Title
5-year survival
Description
Number of Deaths occurring within 5 years after EAS
Time Frame
From inclusion in study and up to five years after EAS.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ib Jammer, MD, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

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Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

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