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Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor

NCT05173467 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-30

No results posted yet for this study

Summary

With significant advances in diagnostic imaging and systemic therapies for oncologic disease, spinal metastasis with neurological dysfunction and mechanical instability has become an indication for surgery. Even if traditional-open surgery was palliative, the treatment of spinal metastasis also carried significant surgical morbidity. Those high morbidity and complication rates may influence the quality of patients with a limited life expectancy. Invasion-controlled surgery was utilized with Robot-assisted surgery approach against symptomatic spinal metastasis.

Increasing interest in the potential for improved consistency, complication reduction, and decreased length of hospitalization through robot utilization is evident from the rapid growth of publications seen in recent years.

So, the investigators wish to evaluate the advantages of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery spinal surgery in patients with metastatic spinal cord compression.

Conditions

  • Minimally Invasive Surgery
  • Spinal Metastases

Interventions

PROCEDURE

Robot-assisted Invasion-controlled Surgery

The concept of invasion-controlled surgery (ICS) for spinal metastasis has been put forward against the spinal instability and neurological dysfunction of frail patients that might not allowed for radical traditional open surgery including improvements of multidisciplinary dynamic assessments, endovascular detachable balloon embolization, minimal-invasion by using expandable working tubes, percutaneous pedicle screws, and some accurate therapy. ICS could provide immediate stability, deformity correction, and recovery of neurological function.

PROCEDURE

Traditional-open Surgery

This traditionally requires a midline incision, bilateral muscle strip, and multilevel laminectomy to provide adequate access and safe removal of the tumor.

Sponsors & Collaborators

  • Wei Xu

    lead OTHER

Principal Investigators

  • Jianru Xiao, Profession · Shanghai Changzheng Hospital

  • Wei Xu, Profession · Shanghai Changzheng Hospital

  • Bo Li, Profession · Shanghai Changzheng Hospital

  • Pengru Wang, Profession · Shanghai Changzheng Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-25
Primary Completion
2022-12-10
Completion
2023-12-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05173467 on ClinicalTrials.gov