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Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Study acronym: POTHeR
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Enrolling by Invitation to Recruiting
    • Study sites: 1 to 3
    v4
  2. Trial status: Active, Not Recruiting to Enrolling by Invitationv3
  3. Eligibility criteria shortened, about 11 wordsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06911736
Lead Sponsor Universidad de Antioquia
Conditions
(from sponsor)		 Chronic Subdural Hematoma, Trendelenburg, Recurrence, Mortality, Prognosis, Clinical Trials
Related terms Hematoma, Subdural, Chronic, Recurrence
Enrollment 254 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov