Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06911736

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Led by Universidad de Antioquia · Updated on 2025-04-22

254

Participants Needed

3

Research Sites

151 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Symptomatic chronic subdural hematoma confirmed by CT scan
  • Requires surgical management
  • Provided informed consent or consent given by a responsible family member
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding
  • Conditions where Trendelenburg position is unsafe, including intracranial hypertension without a drain, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without secure airway, glaucoma, unstable spinal cord trauma, peripheral vascular disease
  • History of ipsilateral chronic subdural hematoma drainage
  • Intracranial hypotension syndrome
  • Ventriculoperitoneal shunting
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

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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

CONTACT

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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