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

Haukeland University Hospital

Status: Completed

Conditions: Post-Op Complication; Gastro-Intestinal Disorder; Surgery--Complications; Frailty; Outcome, Fatal; Frail Elderly Syndrome

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04293653

REK7110

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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156 participants in 1 patient group

Care bundle

Experimental group

Description:

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.

Treatment:

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