Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

Not Applicable

Recruiting

• Conditions: Chronic Subdural Hematoma; Trendelenburg; Recurrence; Mortality; Prognosis; Clinical Trials

• Registration Number: NCT06911736
• Lead Sponsor: Universidad de Antioquia

Brief 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).

Study Timeline

• Status Verified: 2024-05
• Study Start: 2024-06-01
• Primary Completion: 2025-02-28
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-27
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• 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

Exclusion Criteria

• Pregnant or breastfeeding
• Conditions in which the trendelenburg position might not be safe, such as intracranial hypertension without a drain to allow evacuation of the hematoma, cardiovascular instability (severe heart failure, unstable angina, cardiogenic pulmonary edema), acute respiratory distress syndrome without a secure airway, glaucoma, spinal cord trauma not stabilized with surgery, peripheral vascular disease,
• History of ipsilateral chronic subdural hematoma drainage, intracranial hypotension syndrome, ventriculoperitoneal shunting
• Simultaneous participation in any other clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence	3 months	Proportion of patients who experienced recurrence of chronic subdural hematoma at 3 months of follow-up and required repeat surgery

Secondary Outcome Measures

Name	Time	Method
proportion of patients with favorable functional outcome at 3 months, as measured by the modified Rankin Scale.	3 months	Secondary outcomes were the proportion of patients with favorable functional outcome at three months, as measured by the modified Rankin Scale (mRS). The validated scale has seven categories: no symptoms (0), no clinically significant disability despite symptoms (1), mild disability (2), moderate disability (3), moderately severe disability (4), severe disability (5), and death (6); in this trial, a score of 0 to 2 was considered a favorable outcome, as it is associated with functional independence.

Trial Locations

Locations (3)

Clinica CES; 🇨🇴 Medellin, Antioquia, Colombia

Instituto Neurologico de Colombia; 🇨🇴 Medellin, Antioquia, Colombia

Hospital San Vicente Fundación; 🇨🇴 Medellin, Antioquia, Colombia