Observational Study of Sacral Nerve Function After Sacral Tumor Resection
ConditionSacral Tumors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorShanghai Changzheng Hospital
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population includes patients aged 12 to 80 years diagnosed with sacral tumors (either primary bone tumors or metastases from other solid tumors) who are scheduled for surgical resection at Shanghai Changzheng Hospital. All participants must meet inclusion criteria and provide informed consent. The study will assess postoperative motor, bowel, and bladder function, pain, quality of life, and complications. Patients unable to tolerate surgery or with pre-existing bowel/bladder dysfunction will be excluded. A total of 400 patients will be enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 1 trial groupGroup A: Sacral Tumor Resection Post-Surgery Cohort
Trial outcomes
Primary outcomes
1
Bladder Function Score at 12 Months Post-Surgery
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
Time frame
12 months post-surgery: Bladder function will be assessed during a comprehensive follow-up visit at 12 months after the surgery.Secondary outcomes
1
Rectal Function Score at 12 Months Post-Surgery
The secondary outcome measure will assess rectal 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 Rectal function scoring system commonly used in sacrectomy outcome studies includes the following components: 0-Normal 1. Feels stimulus to defecate and is incontinent when feces are soft or under stress 2. Does not feel stimulus to defecate and/or is completely incontinent
Time frame
12 months post-surgery: Rectal function will be assessed during a follow-up visit at 12 months after the surgery.Other outcomes
1
Pre-Surgical Baseline Information-Age
Patient age at the time of surgery, recorded in years as a continuous variable.
Time frame
2 days before surgery: The pre-surgical baseline information will be collected during the patient's preoperative assessment, which will occur 2 days before the surgery.2
Pre-Surgical Baseline Information-Gender
Patient sex as recorded in the medical record (male or female).
Time frame
2 days before surgery: The pre-surgical baseline information will be collected during the patient's preoperative assessment, which will occur 2 days before the surgery.3
Pre-Surgical Baseline Information-Time from Treatment Initiation to First Diagnosis
The duration, in months, between the initiation of any relevant prior treatment (e.g., symptomatic management, imaging, or biopsy) and the date of histopathological diagnosis of sacral tumor
Time frame
2 days before surgery: The pre-surgical baseline information will be collected during the patient's preoperative assessment, which will occur 2 days before the surgery.4
Pre-Surgical Baseline Information-Body Mass Index (BMI)
Calculated as weight in kilograms divided by height in meters squared (kg/m²), recorded as a continuous variable.
Time frame
2 days before surgery: The pre-surgical baseline information will be collected during the patient's preoperative assessment, which will occur 2 days before the surgery.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: