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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 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • Duarte, California, Vereinigte Staaten, 91010
        • City of Hope Medical Center
        • Kontakt:
        • Hauptermittler:
          • Alana M. Munger

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Diagnostic (Intraoperative neuromonitoring)
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
Sonstiges: Umfrageverwaltung
Nebenstudien
Verfahren: Chirurgische Prozedur
Unterziehen Sie sich einer standardmäßigen Operation
Andere Namen:
  • Betrieb
  • Chirurgie
  • Art der Operation
  • Chirurgisch
  • Operativer Eingriff
  • Chirurgische Eingriffe
  • Chirurgische Maßnahmen
  • Chirurgie, NOS
Verfahren: Intraoperative Nerve Monitoring
Undergo intraoperative neuromonitoring
Andere Namen:
  • IONM
  • Intraoperative Neuromonitoring
  • Intraoperative Neurophysiological Monitoring

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Distribution of BCR reflex parameters
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 BCR amplitude
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
From baseline, up to 1 year
Lower extremity function
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

City of Hope Medical Center

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Alana M Munger, City of Hope Medical Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Januar 2027

Primärer Abschluss (Geschätzt)

10. Juni 2029

Studienabschluss (Geschätzt)

10. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

10. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

16. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25826 (Andere Kennung: City of Hope Medical Center)
  • P30CA033572 (US NIH Stipendium/Vertrag)
  • NCI-2026-04599 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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