protocolSection identificationModule nctId: NCT06337851, orgStudyIdInfo id: AtaturkTRH2003/9, briefTitle: Comparing Simultaneous and Consecutive Drainage of Bilateral Chronic Subdural Hematoma, statusModule overallStatus: COMPLETED, startDateStruct date: 2003-11, primaryCompletionDateStruct date: 2010-04, completionDateStruct date: 2011-04, studyFirstPostDateStruct date: 2024-03-29, lastUpdatePostDateStruct date: 2024-03-29, sponsorCollaboratorsModule leadSponsor name: Ataturk Training and Research Hospital, class: OTHER, descriptionModule briefSummary: Surgical evacuation CSDH via burr hole craniostomy appears to be the most widely practiced treatment technique worldwide and outcomes are generally favorable.In previous reports, bilateral CSDH was raised as a predictor of rapid deterioration and worse outcomes attributable to brain herniation, in comparison with unilateral ones. Nevertheless, the optimal surgical considerations in bilateral CSDH still remain controversial. Thus, this study principally aims to finding out whether consecutive removal of bilateral CSDH really poses a complication risk. The secondary objectives of the study were to obtain information about the one-year prognosis of bilateral CSDH and to find factors that affect the prognosis, if any.Inclusion criteria Symptomatic adult (≥18 years-old) patients with bilateral hemispheric CSDHExclusion criteria Patients with hematoma thickness smaller than 10 mm on either side, and those who previously underwent any cranial surgeryRandomization Simple randomization, without blocking, will be used to divide patients into two groups simultaneous burr hole craniostomy (Group-1) and consecutive burr hole craniostomy (Group-2).Clinical Evaluation Neurological examination and scoring systems (Glasgow coma scale and Markwalder Grading) will be used.Radiological Evaluation Radiological evaluations will be made with CT and MR imaging.Operation Patients in group-1 were fixed in supine position with their heads in neutral and flexion position. Bilateral burr holes were made one after another, the dural surfaces were exposed at the same time, then the outer membranes of both sides opened and hematomas evacuated simultaneously. All the patients underwent a drainage system, performed with the insertion of a silicone tube into the subdural space and tunneled under the scalp to the exit point. In group-2, hematoma with a greater thickness was removed first (if thickness was equal on both sides, first incision was made on the right side). The head in supine position was rotated to the side with a smaller hemorrhage thickness. Previously, burr holes were made, the dural surfaces were exposed, the outer membrane opened, and the hematoma was evacuated at one side. Then, drainage system inserted into the subdural space. After the procedure of the first side was completed, as a consecutive process, the head was rotated to the other side, and the same procedure was repeated. The contralateral hematoma was evacuated.Follow-Up Depending on the subdural fluid collected, all drains will be removed within post-operative 36-48 hours.Only the patients with epileptic history and on epileptic medication will receive postoperative antiepileptics.In the postoperative period, a comprehensive evaluation encompassing neurological examinations and CT imaging will be performed.This evaluation protocol will be executed immediately following the surgical procedure, after the removal of surgical drains (usually on the second postoperative day), and at designated intervals of the 1st, 3rd, 6th, and 12th months to monitor patient progress and recovery., conditionsModule conditions: Subdural Hematoma, Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: a prospective randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 43, type: ACTUAL, armsInterventionsModule interventions name: Simultaneous burr hole craniostomy, interventions name: Consecutive burr hole craniostomy, outcomesModule primaryOutcomes measure: The Primary Outcome: Mortality, primaryOutcomes measure: The Primary Outcome: Early Postoperative Success Rate (Redo Surgery), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Age), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Sex), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Trauma-Relation), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Concomitant Pathologies), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (The Glasgow Coma Scale), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (The Markwalder Grading Scale), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Neurological Examination - Motor), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Neurological Examination - fundus oculi), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Neurological Examination - babinski sign), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Radiological Assessments - midline shift), secondaryOutcomes measure: The secondary outcome: Follow-up assessment (Radiological Assessments - hematoma volum), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Izmir Ataturk Training and Research Hospital, city: Izmir, zip: 35360, country: Turkey, geoPoint lat: 38.41273, lon: 27.13838, hasResults: False