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NCT Number: NCT06911736

Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

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).

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Key information

Conditions

Chronic Subdural Hematoma Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Clinical Trials Craniocerebral Trauma Disease Attributes Hematoma Hematoma, Subdural Hematoma, Subdural, Chronic Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Mortality Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Prognosis Recurrence Trauma, Nervous System Trendelenburg Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinica CES, Medellín, Antioquia, Colombia

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trendelenburg position

Other

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.

Primary outcomes

  1. Recurrence

    Time frame: 3 months

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

Secondary outcomes

  1. proportion of patients with favorable functional outcome at 3 months, as measured by the modified Rankin Scale.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jorge H Montenegro, Neurosurgery resident

CONTACT

[email protected]

+573117727801

Sponsors and collaborators

Lead sponsor

Universidad de Antioquia

Other

Registry information

Official study title

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

Acronym: POTHeR

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Apr 4, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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