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

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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome; Frailty; Surgery--Complications; Outcome, Fatal; Post-Op Complication; Gastro-Intestinal Disorder
• Intervention / Treatment: Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy

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: Interventional
• Enrollment (Actual): 156
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

1

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.

Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy; See above section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
30-day mortality in all patients with indication to undergo surgery	30-day mortality rate in palliative and operated patients	Time (days) up to 30 days after treatment decision (palliation or surgery) is made

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year survival	Number of deaths occuring within 3 years after EAS	Time (days) from end of index surgery and up to 3 years after EAS.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Ib Jammer, MD, PhD

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: March 2, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Postoperative Complications
• Other Study ID Numbers: REK7110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No