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
- Frailty
- Surgery--Complications
- Outcome, Fatal
- Frail Elderly Syndrome
- Post-Op Complication
- Gastro-Intestinal Disorder
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy | See 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.