Bone Neoplasm, Metastatic Malignant Neoplasm in the Bone
Conditions
Brief 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.
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
PROCEDUREIntraoperative Nerve Monitoring
Undergo intraoperative neuromonitoring
PROCEDURESurgical Procedure
Undergo standard of care surgery
OTHERSurvey Administration
Ancillary studies
Sponsors
City of Hope Medical Center
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of BCR reflex parameters | From baseline, Up to 1 year | Amplitude, latency, frequency distribution, etc, measured via intraoperative neuromonitoring (IONM). ), Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for BCR for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter. |
| Distribution of EUS reflex parameters | From baseline, Up to 1 year | Amplitude, latency, frequency distribution, etc, measured via IONM. Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for EUS for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter. |
| Change in BCR reflex parameters | From baseline, Up to 1 year | Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for BCR for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter. |
| Change in EUS reflex parameters | From baseline, Up to 1 year | Analyses will first be conducted separately within thoracolumber and sacrectomy patient groups. Descriptive statistics will be reported for EUS for each group. Next, to compare the mean values between the two groups, t-test or Mann-Whitney U-test will be implemented depending on the distribution of these parameters. Additionally, within the sacrectomy group, the changes of these parameters from baseline to the end-of-case will be assessed either through paired t-test or Wilcoxon's signed rank test, depending on the distribution of each parameter. |
| Relative contribution of individual right sacral nerve roots to BCR amplitude | During intraoperative stimulation, Up to Day 21 | Amplitudes among sacrectomy patients will be descriptively reported. |
| Relative contribution of individual left sacral nerve roots to BCR amplitude | During intraoperative stimulation, Up to Day 21 | Amplitudes among sacrectomy patients will be descriptively reported. |
| Relative contribution of individual right sacral nerve roots to EUS amplitude | During intraoperative stimulation, Up to Day 21 | Amplitudes among sacrectomy patients will be descriptively reported. |
| Relative contribution of individual left sacral nerve roots to EUS amplitude | During intraoperative stimulation, Up to Day 21 | Amplitudes among sacrectomy patients will be descriptively reported. |
| Bowel function scores | From baseline, Up to 1 year | Assessed by Memorial Sloan Kettering Bowel Function Instrument. Will be described by graphs and descriptive statistics at each time point. |
| Bladder function scores | From baseline, up to 1 year | Assessed by International Consultation on Incontinence Questionnaire. Will be described by graphs and descriptive statistics at each time point. |
| Sexual function scores | From baseline, up to 1 year | Assessed by Female Sexual Function Index (female patients only) and International Index of Erectile Function (male patients only). Will be described by graphs and descriptive statistics at each time point. |
| Lower extremity function | From baseline, up to 1 year | Assessed by Toronto Extremity Salvage Score for the Lower Extremity. Will be described by graphs and descriptive statistics at each time point. |
| Quality of life | From baseline, up to 1 year | Assessed by Functional Assessment of Cancer Therapy-General. Will be described by graphs and descriptive statistics at each time point. |
| Postoperative urologic function | From baseline, up to 1 year | Assessed by post-void residual (PVR) or cystometry. Will be described by graphs and descriptive statistics at each time point. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlana M Munger
City of Hope Medical Center
Outcome results
None listed