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
10 de julio de 2026 actualizado por: City of Hope Medical Center
Phase 2a Prospective Study of Intraoperative Neuromonitoring of the Bulbocavernosus and External Urethral Sphincter Reflexes
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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
California
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Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
-
Contacto:
- Alana M. Munger
- Número de teléfono: 808-384-0975
- Correo electrónico: amunger@coh.org
-
Investigador principal:
- Alana M. Munger
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Diagnostic (Intraoperative neuromonitoring)
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
|
Estudios complementarios
Someterse a cirugía estándar de atención
Otros nombres:
Undergo intraoperative neuromonitoring
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Periodo de tiempo: 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.
|
From baseline, Up to 1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Distribution of BCR reflex parameters
Periodo de tiempo: 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.
|
From baseline, Up to 1 year
|
|
Distribution of EUS reflex parameters
Periodo de tiempo: 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.
|
From baseline, Up to 1 year
|
|
Change in BCR reflex parameters
Periodo de tiempo: 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.
|
From baseline, Up to 1 year
|
|
Change in EUS reflex parameters
Periodo de tiempo: 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.
|
From baseline, Up to 1 year
|
|
Relative contribution of individual right sacral nerve roots to BCR amplitude
Periodo de tiempo: During intraoperative stimulation, Up to Day 21
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Amplitudes among sacrectomy patients will be descriptively reported.
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During intraoperative stimulation, Up to Day 21
|
|
Relative contribution of individual left sacral nerve roots to BCR amplitude
Periodo de tiempo: During intraoperative stimulation, Up to Day 21
|
Amplitudes among sacrectomy patients will be descriptively reported.
|
During intraoperative stimulation, Up to Day 21
|
|
Relative contribution of individual right sacral nerve roots to EUS amplitude
Periodo de tiempo: During intraoperative stimulation, Up to Day 21
|
Amplitudes among sacrectomy patients will be descriptively reported.
|
During intraoperative stimulation, Up to Day 21
|
|
Relative contribution of individual left sacral nerve roots to EUS amplitude
Periodo de tiempo: During intraoperative stimulation, Up to Day 21
|
Amplitudes among sacrectomy patients will be descriptively reported.
|
During intraoperative stimulation, Up to Day 21
|
|
Bowel function scores
Periodo de tiempo: 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.
|
From baseline, Up to 1 year
|
|
Bladder function scores
Periodo de tiempo: 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.
|
From baseline, up to 1 year
|
|
Sexual function scores
Periodo de tiempo: 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.
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From baseline, up to 1 year
|
|
Lower extremity function
Periodo de tiempo: 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.
|
From baseline, up to 1 year
|
|
Quality of life
Periodo de tiempo: 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.
|
From baseline, up to 1 year
|
|
Postoperative urologic function
Periodo de tiempo: 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.
|
From baseline, up to 1 year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alana M Munger, City of Hope Medical Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
10 de enero de 2027
Finalización primaria (Estimado)
10 de junio de 2029
Finalización del estudio (Estimado)
10 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
10 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
10 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
10 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Neoplasias por sitio
- Neoplasias
- Neoplasias Óseas
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Monitoreo, fisiológico
- Monitoreo, intraoperatorio
- Monitoreo neurofisiológico
- Procedimientos quirúrgicos, operativo
- Monitoreo neurofisiológico intraoperatorio
Otros números de identificación del estudio
- 25826 (Otro identificador: City of Hope Medical Center)
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- NCI-2026-04599 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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