Clinical Trials Directory

Trials / Completed

CompletedNCT04293653

Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
156 (actual)
Sponsor
Haukeland University Hospital · Academic / Other
Sex
All
Age
75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERProtocol for patients above 75 undergoing emergency laparotomy or laparoscopySee above section

Timeline

Start date
2020-01-21
Primary completion
2021-06-30
Completion
2024-10-02
First posted
2020-03-03
Last updated
2024-10-04

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04293653. Inclusion in this directory is not an endorsement.