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

Sponsor

Haukeland University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04293653

Collaborator

(none)

140

Enrollment

Location

Arm

30.4

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Frailty Surgery--Complications Outcome, Fatal Frail Elderly Syndrome Post-Op Complication Gastro-Intestinal Disorder	Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy	N/A

Detailed Description

In the "ProPEL" study the investigators will introduce a patient protocol designed for patients above 75 years where emergency laparotomy or laparoscopy is indicated.

Patients with abdominal pathology requiring emergency surgery will be evaluated for frailty by the surgical team using standardized frailty scores.

The results from the scorings indicate whether the patient should be offered surgery or palliation. The clinical decision is made together with the patient and/or relatives in a shared-decision-making process.

If surgery is planned, the patient enters a specific care-bundle for emergency laparotomy. Mortality and morbidity will be analyzed in patients treated according to the principles of this bundle. The bundle will be applied to all patients above 75 years undergoing emergency laparotomy/laparoscopy with a Clinical Frailty Scale scoring from 1-6.

Essential elements in this care-bundle are frailty scoring, surveillance and Optimizing of patients, surgical treatment within pre-defined criteria, and monitoring for delirium postoperatively.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated.A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated.

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Actual Study Start Date :

Jan 21, 2020

Anticipated Primary Completion Date :

Aug 2, 2022

Anticipated Study Completion Date :

Aug 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Care bundle Patients above 75 years where emergency surgery is indicated and with a Clinical Frailty Scale Score of 1-6 will be included in a perioperative care-bundle. While waiting for surgery patients will be monitored and optimized if deteriorating. Antibiotics will be administered if indicated. Surgery is delivered within 2, 6 or 24 h depending on suspected abdominal pathology and clinical condition.	Other: Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy See above section

Arm

Intervention/Treatment

Experimental: Care bundle

Patients above 75 years where emergency surgery is indicated and with a Clinical Frailty Scale Score of 1-6 will be included in a perioperative care-bundle. While waiting for surgery patients will be monitored and optimized if deteriorating. Antibiotics will be administered if indicated. Surgery is delivered within 2, 6 or 24 h depending on suspected abdominal pathology and clinical condition.

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

See above section

Outcome Measures

Primary Outcome Measures

30-day mortality [Up to 30 days after the performance of emergency abdominal surgery]
Number of deaths within 30 days after emergency abdominal surgery

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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