The Effect of Temporal Muscle Suspension of Temporal Hollowing: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Percent change in temporal hallowing
研究概览
简要总结
The primary objective is to identify which patients undergoing a traditional pterional approach with 2 different surgical techniques for TMS (Temporal Muscle Suspension) will develop TH (Temporal Hollowing. Pre and post-operative CT scans will be reviewed and analysis with previously proven metrics will be performed.
详细描述
The pterional approach is an indicated neurosurgical approach commonly used for anterior circular aneurysms, suprasellar lesions, and medial sphenoid wing tumors (1,2). A curvilinear incision from the midline widows peak and extending laterally to 1 cm anterior to the tragus of the ear, terminating within a skin crease, with preservation of the superficial temporal artery if possible. The temporalis fascia is encountered and divided. Either the entire temporalis muscle can be elevated or a cuff of temporalis muscle can be left on the cranium to facilitate closure and suspend the temporalis muscle. Subperiosteal dissection of the muscle is performed and the craniotomies are then accomplished.
Reconstruction of the pterional approach can be accomplished with bony fixation of the bone flap. However, the TMS can be performed by:
- Resuspension of the temporalis muscle to the cuff of muscle left on the temporal crest or
- Suturing the temporalis muscle directly to one of the bone plates that is used to for fixation.
The purpose of this prospective study is see if traditional techniques to the closure and temporal muscle suspension (TMS) after the pterional approach will show any differences in post-operative temporal hollowing (TH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Patients will be given assigned a research limb the morning of the surgery
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •This study will include all patients over the age of 18 years who qualify for a pterional approach for their neurosurgical pathology.
排除标准
- •Excluded patients will be protected populations, such as inmates or children. Patients will not be excluded on the basis of pregnancy.
结局指标
主要结局
Percent change in temporal hallowing
时间窗: 12 months
The primary end point and outcome variable will the CT quantitative evaluation of temporal hollowing. Percent change and volume analysis as compared to the non operated temporal region in a two dimensional and three dimensional view in a CT Scan of the head and face will be the primary outcome variable.
次要结局
- Patient satisfaction for aesthetic results(12 months)