Effect of positioning after surgery on chronic subdural hematoma recurrence
Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial
NA · Universidad de Antioquia · NCT06911736
This study tests if lying in a specific position after surgery can help prevent chronic subdural hematomas from coming back in patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidad de Antioquia (other) |
| Locations | 3 sites (Medellín, Antioquia and 2 other locations) |
| Trial ID | NCT06911736 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate how the postoperative Trendelenburg position affects the recurrence of chronic subdural hematoma (CSH) in patients undergoing surgery. It is an open-label, randomized, controlled trial conducted across three hospitals in Medellín, where patients are assigned to either the Trendelenburg position or a flat bed for 24 hours post-surgery. The study measures CSH recurrence at three months, alongside functional outcomes, adverse events, and patient comfort levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older requiring surgical management for symptomatic chronic subdural hematoma.
Not a fit: Patients with conditions that contraindicate the Trendelenburg position or those with specific medical histories may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative care and reduced recurrence rates of chronic subdural hematoma.
How similar studies have performed: While the approach is novel in this specific context, similar studies have explored postoperative positioning effects, but results may vary.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Medellín, Antioquia and 2 other locations
- Clinica CES — Medellín, Antioquia, Colombia (RECRUITING)
- Hospital San Vicente Fundación — Medellín, Antioquia, Colombia (RECRUITING)
- Instituto Neurologico de Colombia — Medellín, Antioquia, Colombia (RECRUITING)
Study contacts
- Study coordinator: Jorge H Montenegro, Neurosurgery resident
- Email: montenegromjh@gmail.com
- Phone: +573117727801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Subdural Hematoma, Trendelenburg, Recurrence, Mortality, Prognosis, Clinical Trials