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 juli 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
50
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
California
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Duarte, California, Verenigde Staten, 91010
- City of Hope Medical Center
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Contact:
- Alana M. Munger
- Telefoonnummer: 808-384-0975
- E-mail: amunger@coh.org
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Hoofdonderzoeker:
- Alana M. Munger
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Diagnostic (Intraoperative neuromonitoring)
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
|
Nevenstudies
Onderga een standaardbehandeling
Andere namen:
Undergo intraoperative neuromonitoring
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Distribution of BCR reflex parameters
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
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Relative contribution of individual left sacral nerve roots to BCR amplitude
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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From baseline, up to 1 year
|
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Sexual function scores
Tijdsspanne: 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
|
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Lower extremity function
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Alana M Munger, City of Hope Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
10 januari 2027
Primaire voltooiing (Geschat)
10 juni 2029
Studie voltooiing (Geschat)
10 juni 2029
Studieregistratiedata
Eerst ingediend
10 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juli 2026
Eerst geplaatst (Werkelijk)
16 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25826 (Andere identificatie: City of Hope Medical Center)
- P30CA033572 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2026-04599 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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