Intraoperative Neuromonitoring of Sacral Reflexes to Predict Post Operative Function in Patients Undergoing Sacrectomy for Pelvic Bone Malignancy or Patients Undergoing Spinal Procedures Without Sacral Root Involvement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative Nerve Monitoring, Surgical Procedure, Survey Administration.
- Who it may be relevant to
- Registry conditions: Bone Neoplasm, Metastatic Malignant Neoplasm in the Bone. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
Overview
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.
Detailed 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 intraoperative neuromonitoring in patients undergoing sacrectomy.
III. To characterize the relative contribution of individual sacral nerve roots to sacral reflex responses during intraoperative stimulation in patients undergoing sacrectomy.
IV. To characterize longitudinal changes in postoperative functional outcomes in patients undergoing sacrectomy.
EXPLORATORY OBJECTIVES:
I. To explore the association between intraoperative sacral reflex changes and postoperative functional outcomes in patients undergoing sacrectomy.
II. To explore the association between sacrifice of higher- versus lower-contributing sacral nerve roots and postoperative functional outcomes in patients undergoing sacrectomy.
OUTLINE:
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
After completion of study treatment, patients are followed up at 21 days, 6 weeks and 3, 6 and 12 months.
Interventions
- Procedure Intraoperative Nerve Monitoring
Undergo intraoperative neuromonitoring - Procedure Surgical Procedure
Undergo standard of care surgery - Other Survey Administration
Ancillary studies
Primary outcome measures
- Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility) [Time frame: From baseline, Up to 1 year]
Secondary outcome measures (12)
- Distribution of BCR reflex parameters [Time frame: From baseline, Up to 1 year]
- Distribution of EUS reflex parameters [Time frame: From baseline, Up to 1 year]
- Change in BCR reflex parameters [Time frame: From baseline, Up to 1 year]
- Change in EUS reflex parameters [Time frame: From baseline, Up to 1 year]
- Relative contribution of individual right sacral nerve roots to BCR amplitude [Time frame: During intraoperative stimulation, Up to Day 21]
- Relative contribution of individual left sacral nerve roots to BCR amplitude [Time frame: During intraoperative stimulation, Up to Day 21]
- Relative contribution of individual right sacral nerve roots to EUS amplitude [Time frame: During intraoperative stimulation, Up to Day 21]
- Relative contribution of individual left sacral nerve roots to EUS amplitude [Time frame: During intraoperative stimulation, Up to Day 21]
- Bowel function scores [Time frame: From baseline, Up to 1 year]
- Bladder function scores [Time frame: From baseline, up to 1 year]
- Sexual function scores [Time frame: From baseline, up to 1 year]
- Lower extremity function [Time frame: From baseline, up to 1 year]
Eligibility criteria
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 cohort)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT07707024 · 25826 · NCI-2026-04599 · 25826 · P30CA033572