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

Not Applicable

• Conditions: Minimally Invasive Surgery; Spinal Metastases
• Interventions: Procedure: Robot-assisted Invasion-controlled Surgery; Procedure: Traditional-open Surgery

• Registration Number: NCT05173467
• Lead Sponsor: Wei Xu

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-13
• Study Start: 2021-12-25
• Study First Submitted QC: 2021-12-25
• Last Update Submitted: 2021-12-25
• Study First Posted: 2021-12-30
• Last Update Posted: 2021-12-30
• Primary Completion: 2022-12-10
• Study Completion: 2023-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-assisted Invasion-controlled Surgery	Robot-assisted Invasion-controlled Surgery	-
Traditional-open Surgery	Traditional-open Surgery	-

Primary Outcome Measures

Name	Time	Method
operative bleeding	Intraoperative	It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.

Secondary Outcome Measures

Name	Time	Method
Creatine kinase levels	less than 2 years	reatine kinase were examined 1 day after operation
Intraoperative fluoroscopy dose	Intraoperative	The product of intraoperative c-arm fluoroscopy times and single fluoroscopy dose
operation time	Intraoperative	Is the time from the beginning of the operation to the end of the incision suture is the total operation time
Intraoperative transfusion volume	Intraoperative	That is the amount of intraoperative red blood cell suspension and plasma input and the incidence of blood transfusion.
VAS Scores	less than 2 years	It isrecorded at1D-3D after surgery (morning, middle and evening assessment every day, in which the most pain of each day was recorded. All patients were standardized to use the same dose of non-steroidal antipyretic and analgesic drugs; if temporary addition of A tablet analgesics was needed, VAS score before use was recorded and the dosage of A tablet was recorded), 2W after surgery, And 3M (long-term postoperative pain)
myoglobin	less than 2 years	myoglobin were examined 1 day after operation
Frankel Scores	less than 2 years	The Frankel Scale for Spinal Cord Injury That Classifies the Extent of the Neurological/Functional Deficit into Five Grades
ODI scores	less than 2 years	The ODI is comprised of 10 questions. The questionnaire asks patients about their ability to manage everyday life and covers intensity of pain, lifting, the ability to care for oneself, ability to walk, the ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Answers are then scored on a 0-5 scale, zero meaning no disability.
Complications	less than 2 years	Postoperative wound complications were observed during the hospital period, including the incidence of wound infection, wound nonunion, wound debridement, and the frequency of massive bleeding, lung infection, urinary tract infection and other complications
Survival time	less than 2 years	Survival time
QOL Scores	less than 2 years	Quality of life (QOL) is a multidimensional concept that measures a person's wellbeing.
resuming time of daily life	less than 2 years	Time spent in bed after surgery was recorded

Trial Locations

Locations (1)

ChangZheng Hospital; 🇨🇳 Shanghai, Shanghai, China