Risk factors of recurrence in chronic subdural hematoma and a proposed extended classification of internal architecture as a predictor of recurrence.
Hussam Hamou, Mohamed Alzaiyani, Rastislav Pjontek...
https://pubmed.ncbi.nlm.nih.gov/35461433Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06911736
Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial
Led by Universidad de Antioquia · Updated on 2025-04-22
254
Participants Needed
3
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effect of using the postoperative Trendelenburg position on the recurrence of chronic subdural hematoma (CSH) in patients who undergo surgery. This randomized, open-label clinical trial aims to see if positioning patients with their legs elevated and head tilted downward after surgery reduces the chance of CSH coming back. The study also measures patients' functional outcomes, adverse events, and comfort levels over a 3-month period. Participants are assigned to one of two groups: the control group receives usual care with the patient lying flat after surgery, and the intervention group is positioned in the Trendelenburg posture with 30° leg elevation and 10° head tilt for 24 hours postoperatively. Proper positioning is checked with a goniometer and maintained until drains are removed. Nurses manage drain occlusion if patients get out of bed. Both groups receive standard neurological monitoring and care following surgery. During the study, patients will be closely monitored in the hospital for at least 24 hours. Researchers will assess the recurrence of CSH at 3 months, along with functional ability using the modified Rankin scale, adverse events, and patient comfort using a Likert scale. The trial is conducted in multiple hospital settings and involves regular clinical monitoring and follow-up. Participation lasts through the 3-month post-surgery period to evaluate outcomes and safety.
CONDITIONS
Brief Title
Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosis of symptomatic chronic subdural hematoma confirmed by CT scan
- Require surgical treatment for chronic subdural hematoma
- Provided informed consent by the patient or responsible family member
You will not qualify if you...
- Pregnant or breastfeeding individuals
- Conditions unsafe for Trendelenburg position, including intracranial hypertension without drain, severe heart failure, unstable angina, cardiogenic pulmonary edema, acute respiratory distress syndrome without secure airway, glaucoma, unstable spinal cord trauma, or peripheral vascular disease
- History of ipsilateral chronic subdural hematoma drainage
- Diagnosis of intracranial hypotension syndrome or ventriculoperitoneal shunting
- Currently participating in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery
Duration - 1 day
Participants undergo surgery to treat chronic subdural hematoma.
1 hospital admission visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 24 hours
Participants are positioned either in the Trendelenburg position or a flat bed for 24 hours after surgery with neurological monitoring and drain management.
Continuous inpatient monitoring during post-operative hospital stay
Post-operative Follow-up
Duration - 3 months
Participants are followed up to assess recurrence of chronic subdural hematoma and functional outcomes at 3 months after surgery.
1 follow-up visit at 3 months (in-person)
Trial Site Locations
Total: 3 locations
1
Clinica CES
Medellín, Antioquia, Colombia, 050001
Actively Recruiting
2
Hospital San Vicente Fundación
Medellín, Antioquia, Colombia, 050001
Actively Recruiting
3
Instituto Neurologico de Colombia
Medellín, Antioquia, Colombia, 050001
Actively Recruiting
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Research Team
J
Jorge H Montenegro, Neurosurgery resident
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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