Observational Study of Sacral Nerve Function After Sacral Tumor Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Left Celiac Plexus Resection for Pancreatic Cancer at the Body and Tail

NCT02117895

Pancreatic Cancer

UNKNOWN PHASE3

Sacral Chordoma: Surgery Versus Definitive Radiation Therapy in Primary Localized Disease

NCT02986516

Chordoma

RECRUITING NA

Perioperative Residual Adrenal Function After Extended Resection for Retroperitoneal Soft Tissue Sarcomas

NCT04225494

Adrenal; Functional Disturbance Retroperitoneal Sarcoma Intraoperative Hypotension

COMPLETED

Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

NCT06146946

Rectal Cancer

RECRUITING NA

Resection of the Nerve Plexus on the Right Half of Celiac and SMA Associated With Extended Pancreatoduodenectomy in the Surgical Treatment for Adenocarcinoma of the Head of Pancreas

NCT02514928

Pancreatic Cancer

UNKNOWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sacral Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sacral Tumor Resection Post-Surgery Cohort

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No