Craniotomy versus Endoscopic Membranectomy in the Treatment of Non-Homogeneous Chronic Subdural Hematoma: A Pilot Randomized Parallel-Group Active-Controlled Trial (EMiT CSDH 2).
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Abstract
Background: Chronic subdural hematoma (CSDH) is a prevalent neurosurgical condition with persistent challenges related to recurrence. Endoscopic membranectomy (EM) has shown promising results in managing symptomatic non-homogenous (SNH)-CSDH, but comparative evidence against craniotomy with membranectomy (CM) is lacking.
Objectives: To compare the safety and efficacy of EM versus CM in managing SNH-CSDH.
Materials and methods: A pilot randomized parallel-group active-controlled open- labeled superiority trial from September 2023 to November 2024 at Government Kilpauk Medical College, Chennai, India. Sixty patients with SNH-CSDH were randomized into EM and CM groups. Recurrence was the primary outcome. Secondary outcomes included operative time, complications, radiological indices, pain, hospital stay, and functional recovery. All patients were followed for six months.
Results: No recurrence was observed in either group at six months. Two CM patients required reoperation on postoperative day one ( P = 0.15). EM was associated with shorter operative time ( P = 0.02), lower incidence of post-operative subdural residual fluid ( P = 0.015), better early hematoma reduction/subdural space reduction index ( P = 0.008), midline shift/symmetry improvement index ( P = 0.001), and lesser surgical site swelling ( P < 0.001). All patients were ambulant and had a Glasgow coma scale (GCS) 15 at discharge and at six months (including reoperated patients). Pain scores and functional recovery were comparable. EM patients had shorter hospital stays ( P = 0.004) and no significant complications.
Conclusion: EM demonstrated favorable early radiological outcomes, fewer complications, and comparable functional recovery and recurrence versus CM in SNH-CSDH. Independent reproduction and larger multicentric trials are needed for validity and generalizability.
期刊介绍：
Neurology India (ISSN 0028-3886) is Bi-monthly publication of Neurological Society of India. Neurology India, the show window of the progress of Neurological Sciences in India, has successfully completed 50 years of publication in the year 2002. ‘Neurology India’, along with the Neurological Society of India, has grown stronger with the passing of every year. The full articles of the journal are now available on internet with more than 20000 visitors in a month and the journal is indexed in MEDLINE and Index Medicus, Current Contents, Neuroscience Citation Index and EMBASE in addition to 10 other indexing avenues.
This specialty journal reaches to about 2000 neurologists, neurosurgeons, neuro-psychiatrists, and others working in the fields of neurology.
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