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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 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

50

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • Duarte, California, États-Unis, 91010
        • City of Hope Medical Center
        • Contact:
          • Alana M. Munger
          • Numéro de téléphone: 808-384-0975
          • E-mail: amunger@coh.org
        • Chercheur principal:
          • Alana M. Munger

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Diagnostique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Diagnostic (Intraoperative neuromonitoring)
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
Autre: Administration de l'enquête
Etudes annexes
Procédure: Opération chirurgicale
Subir la norme de soins chirurgicaux
Autres noms:
  • Opération
  • Type de chirurgie
  • Chirurgical
  • Intervention chirurgicale
  • Interventions chirurgicales
  • Chirurgie, SAI
Procédure: Intraoperative Nerve Monitoring
Undergo intraoperative neuromonitoring
Autres noms:
  • IONM
  • Intraoperative Neuromonitoring
  • Intraoperative Neurophysiological Monitoring

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Distribution of BCR reflex parameters
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

City of Hope Medical Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chercheur principal: Alana M Munger, City of Hope Medical Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

10 janvier 2027

Achèvement primaire (Estimé)

10 juin 2029

Achèvement de l'étude (Estimé)

10 juin 2029

Dates d'inscription aux études

Première soumission

10 juillet 2026

Première soumission répondant aux critères de contrôle qualité

10 juillet 2026

Première publication (Réel)

16 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

16 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 25826 (Autre identifiant: City of Hope Medical Center)
  • P30CA033572 (Subvention/contrat des NIH des États-Unis)
  • NCI-2026-04599 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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