Observational Study of Sacral Nerve Function After Sacral Tumor Resection

Обзор

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)

Подробное описание

This observational study is designed to assess the long-term impact of sacral tumor resection on sacral nerve function in patients diagnosed with primary sacral tumors, such as chordomas and chondrosarcomas. The objective is to determine the relationship between the level of sacral resection and the preservation of bowel, bladder, motor, and sexual functions post-surgery. The study will track functional recovery over 12 months, focusing on how different resection levels affect these outcomes.

The study will include patients who undergo sacral tumor resection with varying degrees of nerve root sacrifice. Participants will be categorized based on the extent of resection: those who undergo a low sacrectomy and those who undergo a high sacrectomy.

The primary research questions are:

How does the level of sacral resection (low, middle, high, or total) impact functional outcomes such as bowel, bladder, motor, and sexual function at 12 months post-surgery?

How does the preservation of the sacral nerve root affect functional recovery compared to the sacrifice of this nerve root?

To address these questions, participants will complete a series of standardized questionnaires at baseline, 3 months, 6 months, and 12 months after surgery to assess:

Bowel Function: Evaluated using anorectal manometry and the Cleveland Constipation Score and Wexner Incontinence Score.

Bladder Function: Assessed through ICIQ-SF (bladder function), Saito grading, and urodynamic tests (e.g., maximum urinary flow, post-void residual urine).

Motor Function: Evaluated through Frankel scores and mobility assessments.

Sexual Function: Measured using the IIEF for males and the FSFI for females.

This study will provide important data on the functional outcomes of sacral tumor resection, helping to guide clinical decisions on surgical techniques and post-surgical management to optimize patient recovery and quality of life.

Первичные конечные точки

• Bladder Function Score at 12 Months Post-Surgery [Срок оценки: 12 months post-surgery: Bladder function will be assessed during a comprehensive follow-up visit at 12 months after the surgery.]

Вторичные конечные точки (1)

• Rectal Function Score at 12 Months Post-Surgery [Срок оценки: 12 months post-surgery: Rectal function will be assessed during a follow-up visit at 12 months after the surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Changzheng Hospital — Шанхай

Публикации

• Phukan 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
• Moran 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

Идентификаторы

NCT: NCT07105644 · 25SL016

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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