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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Colombia
Clinica CES
RECRUITING
Medellín
Hospital San Vicente Fundación
RECRUITING
Medellín
Instituto Neurologico de Colombia
RECRUITING
Medellín
Contact Information
Primary
Jorge H Montenegro, Neurosurgery resident
montenegromjh@gmail.com
+573117727801
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 254
Treatments
No_intervention: Control
Control group received the usual postoperative care for patients with CSH, which consisted of strict neurological monitoring for at least 24 hours in an inpatient ward or a more complex setting depending on the patient's clinical condition. The head of the patient was positioned neutral (0°), as were the lower limbs, according to institutional care guidelines. The drain (a latex-gloved reservoir or Hemovac drain) was positioned inferior to the head to promote drainage of any subdural debris. Negative pressure was not used except in patients with Hemovac and a subgaleal drain. Typically, after 24 hours of clinical monitoring and symptom improvement, the drain was removed, and the patient was sent home with recommendations and warning signs, if the patient's clinical condition permitted. Postoperative follow-up imaging was not routinely performed as there was no evidence of clinical benefit.
Experimental: Trendelenburg
In 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.
Sponsors
Leads: Universidad de Antioquia

This content was sourced from clinicaltrials.gov