Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence

NCT06911736 | Recruiting DMC

• 1 other identifier: 102024
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 3

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).

Conditions

Chronic Subdural Hematoma; Trendelenburg; Recurrence; Mortality; Prognosis; Clinical Trials

Outcome Measures

Primary Outcomes (1)

• Recurrence

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

  3 months

Secondary Outcomes (1)

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

  3 months

Study Arms (2)

Control

NO INTERVENTION

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.

Trendelenburg

EXPERIMENTAL

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.

Other: Trendelenburg position

Interventions

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.

Trendelenburg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (3)

Clinica CES

Medellín, Antioquia, 050001, Colombia

RECRUITING

Hospital San Vicente Fundación

Medellín, Antioquia, 050001, Colombia

RECRUITING

Instituto Neurologico de Colombia

Medellín, Antioquia, 050001, Colombia

RECRUITING

Related Publications (1)

• Hamou H, Alzaiyani M, Pjontek R, Kremer B, Albanna W, Ridwan H, Clusmann H, Hoellig A, Veldeman M. Risk factors of recurrence in chronic subdural hematoma and a proposed extended classification of internal architecture as a predictor of recurrence. Neurosurg Rev. 2022 Aug;45(4):2777-2786. doi: 10.1007/s10143-022-01790-8. Epub 2022 Apr 23.

  PMID: 35461433 BACKGROUND

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jorge H Montenegro, Neurosurgery resident

CONTACT

+573117727801; montenegromjh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The nature of this intervention did not allow for masking of treatment allocation, so both patients and their care team knew their assigned arm, while outcome assessors and data analysts remained blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: June 1, 2024
• Primary Completion: February 28, 2025
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 22, 2025

Record last verified: 2024-05

Locations

CO (3)