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NCT07707024
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
Conditions: Bone Neoplasm, Metastatic Malignant Neoplasm in the Bone
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: City of Hope Medical Center
Location: City of Hope Medical Center Duarte California
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07707024). StuddyBuddy aggregates publicly available trial information.