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
2026년 7월 10일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
50
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Duarte, California, 미국, 91010
- City of Hope Medical Center
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연락하다:
- Alana M. Munger
- 전화번호: 808-384-0975
- 이메일: amunger@coh.org
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수석 연구원:
- Alana M. Munger
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Diagnostic (Intraoperative neuromonitoring)
Patients undergo neuromonitoring of the sacral reflexes at predefined time points during standard of care surgery.
|
보조 연구
표준 치료 수술을 받습니다.
다른 이름들:
Undergo intraoperative neuromonitoring
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Reproducible and interpretable bulbocavernosus reflex (BCR) and external urethral sphincter (EUS) reflex responses (feasibility)
기간: 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.
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From baseline, Up to 1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Distribution of BCR reflex parameters
기간: 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.
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From baseline, Up to 1 year
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|
Distribution of EUS reflex parameters
기간: 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.
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From baseline, Up to 1 year
|
|
Change in BCR reflex parameters
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
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From baseline, Up to 1 year
|
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Bladder function scores
기간: From baseline, up to 1 year
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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
|
|
Sexual function scores
기간: 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
기간: From baseline, up to 1 year
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Assessed by Toronto Extremity Salvage Score for the Lower Extremity.
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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Quality of life
기간: From baseline, up to 1 year
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Assessed by Functional Assessment of Cancer Therapy-General.
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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Postoperative urologic function
기간: From baseline, up to 1 year
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Assessed by post-void residual (PVR) or cystometry.
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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Alana M Munger, City of Hope Medical Center
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2027년 1월 10일
기본 완료 (추정된)
2029년 6월 10일
연구 완료 (추정된)
2029년 6월 10일
연구 등록 날짜
최초 제출
2026년 7월 10일
QC 기준을 충족하는 최초 제출
2026년 7월 10일
처음 게시됨 (실제)
2026년 7월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 10일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 25826 (기타 식별자: City of Hope Medical Center)
- P30CA033572 (미국 NIH 보조금/계약)
- NCI-2026-04599 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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