• Medicine · Dec 2016

    Randomized Controlled Trial

    The effect of fenestration of the lamina terminalis on the incidence of shunt-dependent hydrocephalus after aneurysmal subarachnoid hemorrhage (FISH): Study protocol for a randomized controlled trial.

    • Chuanyuan Tao, Chaofeng Fan, Xin Hu, Junpeng Ma, Lu Ma, Hao Li, Yi Liu, Hong Sun, Min He, and Chao You.
    • Stroke Clinical Research Unit, Department of Neurosurgery, West China Hospital, Sichuan University, Chengdu, P. R. China.
    • Medicine (Baltimore). 2016 Dec 1; 95 (52): e5727.

    BackgroundShunt-dependent hydrocephalus (SDH) is a well-known sequela following aneurysmal hemorrhage, adversely affecting the outcome after securing ruptured aneurysm. Fenestration of lamina terminalis (FLT) creates an anterior ventriculostomy, facilitates cerebrospinal fluid circulation and clot clearance in the basal cistern. However, controversy exists over whether microsurgical FLT during aneurysm repair can decrease the incidence of SDH.AimsThe study is designed to determine the efficacy of lamina terminalis fenestration on the reduction of SDH after aneurysm clipping.Methods/DesignA total of 288 patients who meet the inclusion criteria will be randomized into single aneurysm clipping or aneurysm clipping plus FLT in the Department of Neurosurgery, West China Hospital. Follow-up was performed 1, 3, 6, and 12 months after aneurysm clipping. The primary outcome is the incidence of SDH and the secondary outcomes include cerebral vasospasm, functional outcome evaluated by the modified Rankin Scale and Extended Glasgow Outcome Scale, and mortality.DiscussionThe FISH trial is a large randomized, parallel controlled clinical trial to define the therapeutic value of FLT, the results of which will help to guide the surgical procedure and resolve the long-puzzled debate in the neurosurgical community.ConclusionsThis protocol will determine the efficacy of FLT in the setting of aneurysmal subarachnoid hemorrhage.Trial Registration IdentifierCHINESE CLINICAL TRIAL REGISTRY:: ChiCTR-INR-16009249.

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