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IRCT20190618043934N14 IRCT 2022-02-19 Hamedan University of Medical Sciences Comparison of neuroendoscopic and non-endoscopic surgical techniques in treatment of septated chronic subdural hematoma Comparison of neuroendoscopic and non-endoscopic surgical techniques in treatment of septated chronic subdural hematoma 2022-03-20 anticipated 30 Complete https://irct.ir/trial/61946 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study were randomly divided into two groups using simple blocking method: 1) endoscopic surgery intervention (A) or 2) control, naked (single or double bare) surgery (B). They will be. In this way, various quadrilateral blocks are first created using a sealed envelope (AABB, BBAA, ABAB, BABA, ABBA and BABA). One of these blocks is selected randomly and according to the order mentioned in the selected block, patients will be divided into one of two groups A or B. Then randomization is performed for other patients in the same way, Blinding description: Outcome Assessor: The study facilitator (hands in the field of neurosurgery) will assess the outcome during surgery, hospitalization and 6 months after discharge without knowing the patients in the surgery group. Patients participating in the study are not aware of being in the surgical group due to anesthesia and unfamiliarity with surgical methods. Analyzer: The data analyst is also unaware of the inclusion of individuals in the study and analyzes the data using defined codes. 3 Subdural hematoma. Intervention 1: Intervention group: Patients who undergo endoscopic surgery. Intervention 2: Control group: Patients who undergo surgery to perform surgery in the Brahol method (single or double Brahol). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no need to publish individual patient information
public Zabihullah Mohaghegh
No.56, Jorjani Ave, Ghahhari Blvd, Birjand Town
Birjand Iran (Islamic Republic of) 9717934888 +98 56 3232 3232 oabstdent@gmail.com Birjand University of Medical Sciences scientific Dr Fahimeh Esmaeeli
Central Organization of Hamadan University of Medical Sciences.Shahid Fahmideh Street. Research Square. Hamadan. Hamadan Province
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3131 0000 Fahimeh_ee@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Patients with chronic subdural hematoma Patients with CT with Mixed Density Patient consent or patient companion to enter the study no limit no limit Both Patients with low level of consciousness (GCS less than 9) Acute subdural hematoma Patients with multi organ damage Patients with a history of liver cirrhosis Patients with a history of shunt S06.5 Traumatic subdural hemorrhage Treatment - Surgery Treatment - Surgery Intervention group: Patients who undergo endoscopic surgery. Control group: Patients who undergo surgery to perform surgery in the Brahol method (single or double Brahol). Duration of surgery. Timepoint: During surgery in the operating room. Method of measurement: Using field observation and survey. Recurrence rate of surgery. Timepoint: 6 months after discharge. Method of measurement: By examining and performing the relevant tests. Mortality rate. Timepoint: After surgery. Method of measurement: Check mortality statistics. Morbidity. Timepoint: After surgery. Method of measurement: Question from the patient. Duration of hospitalization. Timepoint: After surgery. Method of measurement: Check the patient file. Hamedan University of Medical Sciences Approved 2021-12-10 Ethics Committee of Hamadan University of Medical Sciences Central Organization of Hamadan University of Medical Sciences.Shahid Fahmideh Street. Research Square. Hamadan. Hamadan Province Hamadan Hamadan Iran (Islamic Republic of)