Clinical trial NCT05173467: Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
Official title: Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Minimally Invasive Surgery
Spinal Metastases
Keywords: Minimal surgery
Spinal Metastases
invsasion-controlled surgery
traditional-open surgery
Robot-assisted
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Surgical Spinal Decompression of Metastatic Spinal Cord Compression, Minimal Access Versus Open Surgery. A prospective Clinical Trial

Purpose To investigate the effect of Robot-assisted Invasion-controlled Surgery compared with traditional-open surgery in the treatment of patients with metastatic spinalcord compression.

Hypotheses The group of patient's receiving robot-assisted invasion-controlled surgery will have better improvement in quality after surgery compared to the group that will receive traditional open surgery. The robot-assisted invasion-controlled surgery group will have reduction in per-operative bleeding and less wound complications compered to the group of patients receiving open or traditional surgery.

Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of spinal metastasis (previously confirmed diagnosis of lung cancer, liver cancer, prostate cancer, breast cancer, kidney cancer, digestive tract cancer, imaging indicated the presence of metastatic lesions in the spine)
2. Patients with symptoms of spinal instability or nerve compression (SINS score of spinal instability ≥7, spinal nerve compression according to spinal cord injury Classification, grade A-D)
3. Metastases are located in the thoracic and/or lumbar vertebrae
4. The patient's expected survival was longer than 6 months
5. The subjects or their legal representatives were able to understand the study purpose, demonstrate adequate compliance with the study protocol, and sign informed consent

Exclusion Criteria:

1. He had previously operated on the same site
2. Spontaneous multiple compression fractures of the spine;
3. There is malformed osteitis (Paget's bone disease), osteomalacia, or other metabolic bone disease;
4. here were developmental vertebral malformations or vertebral body and pedicle dysplasia in the spinal segment to be treated by surgery
5. Presence of heart, lung, liver or kidney failure or other serious diseases (such as osteomyelitis, systemic infection, severe hemorrhagic disease, active disseminated intravascular coagulation, serious cardiovascular disease or myocardial infarction within 6 months prior to enrollment, cerebral infarction within 6 months prior to enrollment, severe psychiatric history)
6. Pregnant or lactating women
7. Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment

Primary outcomes:
measure: operative bleeding
timeFrame: Intraoperative
Secondary outcomes:
measure: operation time
timeFrame: Intraoperative
measure: Intraoperative transfusion volume
timeFrame: Intraoperative
measure: Intraoperative fluoroscopy dose
timeFrame: Intraoperative
measure: VAS Scores
timeFrame: less than 2 years
measure: Frankel Scores
timeFrame: less than 2 years
measure: Creatine kinase levels
timeFrame: less than 2 years
measure: myoglobin
timeFrame: less than 2 years
measure: Complications
timeFrame: less than 2 years
measure: QOL Scores
timeFrame: less than 2 years
measure: resuming time of daily life
timeFrame: less than 2 years
measure: Survival time
timeFrame: less than 2 years
measure: ODI scores
timeFrame: less than 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ChangZheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jianru Xiao, Profession
role: STUDY_CHAIR
affiliation: Shanghai Changzheng Hospital
name: Wei Xu, Profession
role: STUDY_DIRECTOR
affiliation: Shanghai Changzheng Hospital
name: Bo Li, Profession
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Changzheng Hospital
name: Pengru Wang, Profession
role: PRINCIPAL_INVESTIGATOR
References: