Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Frailty Clinical Trial

— (ProPEL)  

Official title:

Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04293653
• Other study ID #: REK7110
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2020
• Est. completion date: December 2, 2024

Study information

• Verified date: August 2023
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 156
• Est. completion date: December 2, 2024
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Emergencies
• Frail Elderly Syndrome
• Frailty
• Gastro-Intestinal Disorder
• Gastrointestinal Diseases
• Intestinal Diseases
• Outcome, Fatal
• Post-Op Complication
• Postoperative Complications
• Surgery--Complications

Intervention

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

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality	Number of deaths within 30 days after emergency abdominal surgery	Up to 30 days after the performance of emergency abdominal surgery
Secondary	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
Secondary	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
Secondary	Length of stay in hospital after EAS	Number of days spent in hospital after EAS	up to 90 days after emergency surgery
Secondary	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.
Secondary	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.
Secondary	1-year mortality	Number of deaths within 1 year after emergency abdominal surgery (EAS)	From time of EAS performed and up to 1 year
Secondary	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
Secondary	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.
Secondary	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).
Secondary	5-year survival	Number of Deaths occurring within 5 years after EAS	From inclusion in study and up to five years after EAS.