Clinical trial NCT06911736: Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence
Official title: Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Trendelenburg
Recurrence
Mortality
Prognosis
Clinical Trials
Lead sponsor: Universidad de Antioquia
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Detailed description: Objective: Determine the effect of the postoperative trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery.

Materials and Methods: An open-label, randomized, controlled clinical trial was conducted in three hospitals in Medellín. Patients with CSH were enrolled and assigned to the trendelenburg position (30° leg elevation and 10° head tilt) or a flat bed for 24 hours postoperatively. CSH recurrence was measured at 3 months, along with functional outcome (modified Rankin scale), adverse events, and comfort (Likert scale).

Eligibility criteria: Inclusion Criteria:

* The study included patients aged 18 years or older who required surgical management of symptomatic CSH confirmed by CT scan and whose informed consent was given by the patient or responsible family member to participate in the study

Exclusion Criteria:

* Pregnant or breastfeeding
* Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,
* History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting
* Simultaneous participation in any other clinical trial.

Primary outcomes:
measure: Recurrence
timeFrame: 3 months
Secondary outcomes:
measure: proportion of patients with favorable functional outcome at 3 months, as measured by the modified Rankin Scale.
timeFrame: 3 months
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Clinica CES
state: Antioquia
city: Medellin
country: Colombia
facility: Hospital San Vicente Fundación
state: Antioquia
city: Medellin
country: Colombia
facility: Instituto Neurologico de Colombia
state: Antioquia
Study officials:
References:
citation: Hamou H, Alzaiyani M, Pjontek R, Kremer B, Albanna W, Ridwan H, Clusmann H, Hoellig A, Veldeman M. Risk factors of recurrence in chronic subdural hematoma and a proposed extended classification of internal architecture as a predictor of recurrence. Neurosurg Rev. 2022 Aug;45(4):2777-2786. doi: 10.1007/s10143-022-01790-8. Epub 2022 Apr 23.