Evaluating the Impact of 2D Non-Navigated Intraoperative Ultrasound on Extent of Resection and Patients' Outcome in Glioma Surgery: A Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Extent of tumor resection
研究概览
简要总结
This retrospective study aims to assess the utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective alternative for guiding the surgical resection of gliomas and for detecting residual tumor. The study will analyse the records from consecutive adult patients diagnosed with gliomas, undergoing craniotomy between June 2018 and June 2023. The extent of resection (EOR) will be determined using postoperative MRI as the gold standard. The study will also examine the sensitivity and specificity of ioUS in detecting residual tumor. This research seeks to determine if ioUS can be an affordable and reliable tool that, combined with other intraoperative adjuncts, may aid neurosurgeons in achieving the maximum safe resection in glioma surgery.
详细描述
Objective:
The objective of this retrospective study is to evaluate the effectiveness and utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective method for guiding the surgical resection of gliomas and detecting residual tumor.
Methods:
The study will retrospectively analyze the records of consecutive adult patients diagnosed with gliomas who underwent craniotomy between June 2018 and June 2023. The patients' records must show that they underwent both intraoperative ultrasound and postoperative MRI.
Evaluation Criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older.
- •Patients diagnosed with gliomas, confirmed by a pathologist.
- •Patients who are scheduled to undergo craniotomy for tumor resection.
- •Patients who are willing and able to give informed consent for participation in the trial.
- •Patients who are capable of undergoing both intraoperative ultrasound and postoperative MRI.
排除标准
- •Patients under the age of
- •Patients with non-glioma brain tumors.
- •Patients who underwent stereotactic biopsies.
- •Patients who are unable to provide informed consent due to cognitive impairment, language barriers, or any other reason.
- •Patients with contraindications for MRI such as certain types of implanted medical devices, severe claustrophobia, or allergies to contrast material.
- •Pregnant or breastfeeding women.
结局指标
主要结局
Extent of tumor resection
时间窗: 24 hours after the surgery
Percentage of tumor removal
次要结局
- Postoperative neurological deficit(From 24 hours to 30 days after the surgery)
研究者
Santiago Cepeda
Principal Investigator
Hospital del Río Hortega