Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Not Applicable

Completed

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

• Registration Number: NCT04293653
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study First Submitted: 2020-01-02
• Study Start: 2020-01-21
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-03
• Primary Completion: 2021-06-30
• Status Verified: 2023-08
• Study Completion: 2024-10-02
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Care bundle	Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy	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.

Primary Outcome Measures

Name	Time	Method
Composite score of 30-day mortality and postoperative complications	Up to 30 days after the performance of emergency abdominal surgery	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	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.
Frequency of post-operative delirium	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.
Length of stay in hospital after EAS	up to 90 days after emergency surgery	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	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.
Level of care at discharge from hospital and one year after EAS	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 mortality	From time of EAS performed and up to 1 year	Number of deaths within 1 year after emergency abdominal surgery (EAS)
Days at home in first postoperative year	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
Readmissions after EAS	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
Patient Reported Outcome Measures (PROM)one year after EAS	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.
5-year survival	From inclusion in study and up to five years after EAS.	Number of Deaths occurring within 5 years after EAS
30-day mortality in all patients with indication to undergo surgery	Time (days) up to 30 days after treatment decision (palliation or surgery) is made	30-day mortality rate in palliative and operated patients

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway