Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
研究概览
简要总结
This clinical trial tests how well monitoring the sacral reflexes during surgery (intraoperatively) works to predict the post operative function for patients undergoing removal of the lowest part of the spine (sacrectomy) for pelvic bone cancers or patients undergoing spinal procedures. These surgical procedures can lead to damage to sacral root nerves which can result in impairment to the lower extremities, bowel, bladder, and sexual function. Intraoperative monitoring of sacral reflexes can provide objective, real-time information about pelvic nerve function during surgery. This can aid surgical decision-making and help surgeons better prepare patients to understand the changes that may have occurred to their function as a result of surgery. Intraoperative neuromonitoring may work well to predict postoperative function in patients undergoing sacrectomy for pelvic bone malignancy or patients undergoing spinal procedures.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of acquiring analyzable sacral reflex neuromonitoring data at baseline and case closure during surgery.
SECONDARY OBJECTIVES:
I. To characterize sacral reflex parameters amplitude, latency, waveform morphology, and Nerveana Power Index (NPI) at baseline under standardized intraoperative neuromonitoring conditions in patients undergoing spinal procedures without sacral nerve root involvement and patients undergoing sacrectomy.
II. To describe intraoperative changes in sacral reflex parameters from baseline to end-of-case during standardized intraoperative neuromonitoring in patients undergoing sacrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent of the participant and/or legally authorized representative.
- •Assent, when appropriate, will be obtained per institutional guidelines
- •Age: ≥ 18 years
- •Ability to complete study questionnaires
- •Willingness to comply with all study procedures, including postoperative patient-reported outcome (PRO) assessments
- •Undergoing surgery at City of Hope involving either:
- •Complete or partial sacrectomy for primary or metastatic bone tumors, or
- •Thoracolumbar intervention in which the sacral roots are not exposed or manipulated (reference cohort)
排除标准
- •Prior sacrectomy or prior surgery resulting in complete sacral nerve transection
- •For thoracolumbar cohort patients, prior diagnosis or patient report of bowel or bladder dysfunction
- •Cognitive or psychiatric conditions preventing reliable completion of PRO instruments
结局指标
主要结局
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
时间窗: From baseline, Up to 1 year
Reproducible is defined as the ability to elicit a reflex response on repeated stimulation with consistent waveform presence and morphology at a given timepoint. Interpretable is defined as a recorded reflex response that is distinguishable from background noise and artifact and permits determination of response presence or absence and measurement of latency and amplitude. A two-sided 95% Clopper-Pearson confidence interval will be provided as a measure of precision.
次要结局
- Relative contribution of individual right sacral nerve roots to BCR amplitude(During intraoperative stimulation, Up to Day 21)
- Distribution of BCR reflex parameters(From baseline, Up to 1 year)
- Distribution of EUS reflex parameters(From baseline, Up to 1 year)
- Change in BCR reflex parameters(From baseline, Up to 1 year)
- Change in EUS reflex parameters(From baseline, Up to 1 year)
- Relative contribution of individual left sacral nerve roots to BCR amplitude(During intraoperative stimulation, Up to Day 21)
- Relative contribution of individual right sacral nerve roots to EUS amplitude(During intraoperative stimulation, Up to Day 21)
- Relative contribution of individual left sacral nerve roots to EUS amplitude(During intraoperative stimulation, Up to Day 21)
- Bowel function scores(From baseline, Up to 1 year)
- Bladder function scores(From baseline, up to 1 year)
- Sexual function scores(From baseline, up to 1 year)
- Lower extremity function(From baseline, up to 1 year)
- Quality of life(From baseline, up to 1 year)
- Postoperative urologic function(From baseline, up to 1 year)