Clinical Trials Directory

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RecruitingNCT06911736

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence: a Clinical Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
254 (estimated)
Sponsor
Universidad de Antioquia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Detailed 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).

Conditions

Interventions

TypeNameDescription
OTHERTrendelenburg positionIn addition to the management described above, the postoperative position was modified in the intervention group (trendelenburg). After admission to the hospital unit (general ward, special care, or intensive care unit), the patient's position was adjusted with a 30° leg elevation and a 10° downward head tilt. Proper positioning was verified with a goniometer. This position was maintained until the drains were removed, and the patient was then positioned according to usual care. If the patient decided to get out of bed, the nurse occluded the drains and reopened them when the patient returned to the position described for each group.

Timeline

Start date
2024-06-01
Primary completion
2025-02-28
Completion
2027-04-30
First posted
2025-04-04
Last updated
2025-04-22

Locations

3 sites across 1 country: Colombia

Source: ClinicalTrials.gov record NCT06911736. Inclusion in this directory is not an endorsement.