Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
City of Hope Medical Center
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
Interventions
- ProcedureIntraoperative Nerve Monitoring
Undergo intraoperative neuromonitoring
- ProcedureSurgical Procedure
Undergo standard of care surgery
- OtherSurvey Administration
Ancillary studies
Location
- City of Hope Medical CenterDuarte, California