Effect of the Postoperative Trendelenburg Position on Chronic Subdural Hematoma Recurrence (POTHeR)

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

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 Overview

• Status: Recruiting
• Conditions: Recurrence; Mortality; Prognosis; Chronic Subdural Hematoma; Trendelenburg; Clinical Trials
• Intervention / Treatment: Other: Trendelenburg position

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 Type: Interventional
• Enrollment (Estimated): 254
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jorge H Montenegro, Neurosurgery resident; Phone Number: +573117727801; Email: montenegromjh@gmail.com

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 050001
      • Recruiting
      • Clinica Ces
      • Contact: Juan D Gutierrez, Neurosurgery professor; Phone Number: +573104493044; Email: jdgutierrez@hotmail.com
    • Medellin, Antioquia, Colombia, 050001
      • Recruiting
      • Hospital San Vicente Fundación
      • Contact: Juan D Gutierrez, Neurosurgery professor; Phone Number: +573104493044; Email: jdgutierrez@hotmail.com
    • Medellin, Antioquia, Colombia, 050001
      • Recruiting
      • Instituto Neurológico de Colombia
      • Contact: Yeison E Montoya, Neurosurgery professor; Phone Number: +573165592635; Email: yeisonestebanmontoya@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Trendelenburg position; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	Proportion of patients who experienced recurrence of chronic subdural hematoma at 3 months of follow-up and required repeat surgery	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients with favorable functional outcome at 3 months, as measured by the modified Rankin Scale.	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.	3 months

Collaborators and Investigators

• Sponsor: Universidad de Antioquia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Chronic Disease; Disease Attributes; Hemorrhage; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Intracranial Hemorrhage, Traumatic; Recurrence; Hematoma, Subdural; Hematoma, Subdural, Chronic; Hematoma
• Other Study ID Numbers: 102024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It's not clear to me

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No