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Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Sponsor: Technical University of Munich
Summary
Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-10-01
Completion Date
2026-08
Last Updated
2023-05-16
Healthy Volunteers
No
Conditions
Interventions
Decompressive Laparotomy
As described in the study protocol a long midline laparotomy is performed and open abdomen therapy using negative pressure dressings initiated to lower abdominal pressure and thereby improve venous return from the brain to lower intracranial pressure.
Decompressive Craniectomy
As described in the study protocol a sufficiently sized hemi-craniectomy is performed and the skin closed over the bony defect to allow cerebral swelling and thereby lower intracranial pressure.
Locations (4)
HIA Percy
Clamart, France
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, Germany
Department of Neurosurgery - Klinikum rechts der Isar
Munich, Germany
Bundeswehrkrankenhaus Ulm
Ulm, Germany