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IRCT20220319054332N1 IRCT 2022-04-03 Tehran University of Medical Sciences The effects of intradural optic canal decompression on the visual outcome in suprasellar meningiomas resection The effects of intradural optic canal decompression on the visual outcome in suprasellar meningiomas resection 2022-04-21 anticipated 26 Complete https://irct.ir/trial/62682 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups using a sealed envelope and receive the intervention of the same group. The type of surgery is pre-divided evenly on sheets and sealed in special envelopes. After determining the operation time for each patient, one of the envelopes is opened randomly and the type of patient operation is determined based on its contents, Blinding description: The study will be double-blinded. Patients are blinded to the type of interventions. Patients will then be coded by one of the study partners and the researcher, outcome evaluator, data analyzer will be blinded to the patient group and the type of intervention. N/A suprasellar meningiomas. Intervention 1: Control group: Tumor resection group without intradural decompression of the optic canal. Intervention 2: Intervention group: Tumor resection group with intradural decompression of the optic canal. Yes - There is a plan to make this available What will be shared: Clinical data, treatment outcomes, radiological and ophthalmic findings, and demographic data When: The access period starts 10 months after the results are published To whom: public Conditions: Detailed study information can be provided to qualified researchers interested in treating patients. Where to obtain: corresponded author of article How to obtain: Competent and enthusiastic researchers can obtain data documents after the publication of the work from the corresponded author by providing academic information and identification. Comments:
public Arad Iranmehr
Neurosurgery department, Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
Tehran Iran (Islamic Republic of) 1419733141 00982161190 a-iranmehr@razi.tums.ac.ir Tehran University of Medical Sciences scientific Arad Iranmehr
Neurosurgery ward, Imam Khomeini hospital, Tohid sq., Tehran
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2635 a-iranmehr@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of suprasellar meningioma based on clinical examination and imaging findings. Candidates for tumor resection surgery. On visual examination, at least one eye should have a visual acuity above 0.1 and below 0.7. no limit no limit Both Patients with visual impairment due to damage to the retina, optic nerve, chiasm, or visual cortex for reasons other than suprasellar meningiomas are excluded. Patients who do not agree to continue participating at any stage of the study. Patients who present with tumor recurrence in the same area. Patients who have been diagnosed with a non-meningioma tumor after postoperative pathology report. Patients whose optic nerve is affected by a tumor during surgery Patients with visual acuity below 0.1 in both eyes during the initial preoperative examination. Patients with visual acuity above 0.7 in both eyes during preoperative examinations. Patients with major psychiatric disorders. Patients who do not have adequate access to follow-up at scheduled times. Patients who have a severe reaction to a contrast agent, a metal heart valve, a pacemaker, a non-titanium metal clip, and fear of confinement will not be able to have an MRI. D32.9 Benign neoplasm of meninges, unspecified Treatment - Surgery Treatment - Surgery Control group: Tumor resection group without intradural decompression of the optic canal Intervention group: Tumor resection group with intradural decompression of the optic canal Comparison of the improving the vision of patients with and without intradural decompression of the optic canal after surgery. Timepoint: 3 days, a week, a month, three months after surgery. Method of measurement: Snellen chart or Computerized tests. Comparison of the incidence of surgical complications of suprasellar meningiomas in patients with and without intradural decompression of the optic canal. Timepoint: Three days after admission to the ward. Method of measurement: Based on history and examinations. researcher Approved 2021-01-03 Research Ethics Committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)