Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Last updated: April 16, 2025
Sponsor: Universidad de Antioquia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

Trendelenburg position

Clinical Study ID

NCT06911736
102024
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Conditions in which the trendelenburg position might not be safe, such asintracranial hypertension without a drain to allow evacuation of the hematoma,cardiovascular instability (severe heart failure, unstable angina, cardiogenicpulmonary edema), acute respiratory distress syndrome without a secure airway,glaucoma, spinal cord trauma not stabilized with surgery, peripheral vasculardisease,

  • History of ipsilateral chronic subdural hematoma drainage, intracranial hypotensionsyndrome, ventriculoperitoneal shunting

  • Simultaneous participation in any other clinical trial.

Study Design

Total Participants: 254
Treatment Group(s): 1
Primary Treatment: Trendelenburg position
Phase:
Study Start date:
June 01, 2024
Estimated Completion Date:
April 30, 2027

Study 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).

Connect with a study center

  • Clinica CES

    Medellin, Antioquia 050001
    Colombia

    Active - Recruiting

  • Hospital San Vicente Fundación

    Medellin, Antioquia 050001
    Colombia

    Active - Recruiting

  • Instituto Neurologico de Colombia

    Medellin, Antioquia 050001
    Colombia

    Active - Recruiting

  • Universidad de Antioquia

    Medellin, Antioquia +57
    Colombia

    Site Not Available

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