Clinical trial · Observational
Observational Study of Sacral Nerve Function After Sacral Tumor Resection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate the long-term effects of sacral tumor resection on sacral nerve function in patients with primary sacral tumors, including chordomas and chondrosarcomas. The study will primarily focus on understanding how the level of sacral resection impacts postoperative motor, bowel, bladder, and sexual functions. The main questions it aims to answer are: How does the level of sacral resection influence bowel and bladder function at 12 months post-surgery? What is the role of preserving the sacral nerve root in maintaining motor function and sexual function? Participants will include patients who have undergone sacral tumor resection and will be followed for 12 months post-surgery. They will provide data on their bowel, bladder, and motor functions, as well as sexual function, through clinical evaluations and standardized questionnaires. Participants will: Complete surveys on bowel, bladder, and motor function at baseline and at 3, 6, and 12 months after surgery Undergo clinical assessments, including anorectal manometry, post-void residual urine volume measurements, and sensory evaluations Be evaluated for changes in sexual function using standardized surveys like IIEF (for males) and FSFI (for females)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sacral Tumors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Sacral Tumor Resection Post-Surgery Cohort
- description
- This cohort consists of patients diagnosed with sacral tumors (either primary or metastatic) who have undergone sacral tumor resection surgery. The study focuses on evaluating the post-surgical impact on motor functions, bowel functions, bladder functions, and overall quality of life. Patients in this cohort will be monitored for functional outcomes at various time points post-surgery (2 weeks, 3 months, 6 months, and 12 months). The study also includes a comprehensive assessment of neurological function based on sacral nerve preservation during surgery, including neural root sacrifice and the level of sacral resection performed.
Primary outcomes (1)
- measure
- Bladder Function Score at 12 Months Post-Surgery
- timeFrame
- 12 months post-surgery: Bladder function will be assessed during a comprehensive follow-up visit at 12 months after the surgery.
- description
- The primary outcome measure will assess bladder function 12 months after sacral tumor resection surgery. Based on the Biagini et al. method and supported by literature such as Huang et al the bladder function scoring system commonly used in sacrectomy outcome studies includes the following components: 0-Normal 1. Feels stimulus to micturate and has limited continence at varying times and quantities of urine and/or has increasing postmicturition vesical residual and/or urinary loss in conditions of stress 2. Does not feel stimulus to micturate and/or is completely incontinent
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Age between 12 and 80 years Confirmed diagnosis of sacral tumor (either a primary bone tumor or a metastatic tumor from another solid malignancy) Able to understand the study requirements and provide written informed consent Exclusion Criteria: Poor general condition rendering the patient unable to tolerate surgery History of diseases or surgeries affecting bowel or bladder function Missing intraoperative data regarding sacral resection level or nerve root sacrifice Pregnant or currently breastfeeding Missing critical follow-up data or lost to follow-up
References
Publications (2)
- BACKGROUNDPhukan R, Herzog T, Boland PJ, Healey J, Rose P, Sim FH, Yazsemski M, Hess K, Osler P, DeLaney TF, Chen YL, Hornicek F, Schwab J. How Does the Level of Sacral Resection for Primary Malignant Bone Tumors Affect Physical and Mental Health, Pain, Mobility, Incontinence, and Sexual Function? Clin Orthop Relat Res. 2016 Mar;474(3):687-96. doi: 10.1007/s11999-015-4361-3. PMID 26013155
- BACKGROUNDMoran D, Zadnik PL, Taylor T, Groves ML, Yurter A, Wolinsky JP, Witham TF, Bydon A, Gokaslan ZL, Sciubba DM. Maintenance of bowel, bladder, and motor functions after sacrectomy. Spine J. 2015 Feb 1;15(2):222-9. doi: 10.1016/j.spinee.2014.08.445. Epub 2014 Sep 6. PMID 25195977