Clinical trial NCT04293653: Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
Official title: Protocol for Patients Above 75 Years Undergoing Emergency Laparotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Surgery--Complications
Outcome, Fatal
Frail Elderly Syndrome
Post-Op Complication
Gastro-Intestinal Disorder
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 156
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A care-bundle developed for patients above 75 years undergoing emergency abdominal surgery will be investigated, and the results will be compared to a group of historical controls operated at Haukeland University Hospital in 2016-2017, using 30-day mortality as the primary outcome.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite score of 30-day mortality and postoperative complications
timeFrame: Up to 30 days after the performance of emergency abdominal surgery
Secondary outcomes:
measure: Postoperative complications
timeFrame: up to 90 days after date of emergency surgery
measure: Frequency of post-operative delirium
timeFrame: up to 30 days after emergency surgery
measure: Length of stay in hospital after EAS
timeFrame: up to 90 days after emergency surgery
measure: Patients' Level of independency as measured by the Barthel Activity of Daily Living Index before surgery and one year after surgery
timeFrame: Patients will be assessed with the BArthel ADL-index when admitted to hospital and again one year after emergency abdominal surgery.
measure: Level of care at discharge from hospital and one year after EAS
timeFrame: 1 year after EAS.
measure: 1-year mortality
timeFrame: From time of EAS performed and up to 1 year
measure: Days at home in first postoperative year
timeFrame: From date of discharge from hospital after EAS and up to one year postoperatively
measure: Readmissions after EAS
timeFrame: From 8 hours after primary discharge from hospital after EAS until 30 days after primary discharge.
measure: Patient Reported Outcome Measures (PROM)one year after EAS
timeFrame: One year after procedure performed (EAS).
measure: 5-year survival
timeFrame: From inclusion in study and up to five years after EAS.
measure: 30-day mortality in all patients with indication to undergo surgery
timeFrame: Time (days) up to 30 days after treatment decision (palliation or surgery) is made
Other outcomes:
measure: 3-year survival
timeFrame: Time (days) from end of index surgery and up to 3 years after EAS.
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
name: Ib Jammer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: