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 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Duarte, California, Forenede Stater, 91010
- City of Hope Medical Center
-
Kontakt:
- Alana M. Munger
- Telefonnummer: 808-384-0975
- E-mail: amunger@coh.org
-
Ledende efterforsker:
- Alana M. Munger
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Diagnostic (Intraoperative neuromonitoring)
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
|
Hjælpestudier
Gennemgå standardbehandlingskirurgi
Andre navne:
Undergo intraoperative neuromonitoring
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Distribution of BCR reflex parameters
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alana M Munger, City of Hope Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
10. januar 2027
Primær færdiggørelse (Anslået)
10. juni 2029
Studieafslutning (Anslået)
10. juni 2029
Datoer for studieregistrering
Først indsendt
10. juli 2026
Først indsendt, der opfyldte QC-kriterier
10. juli 2026
Først opslået (Faktiske)
16. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25826 (Anden identifikator: City of Hope Medical Center)
- P30CA033572 (U.S. NIH-bevilling/kontrakt)
- NCI-2026-04599 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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