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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Minimally Invasive Surgery; Spinal Metastases
• Intervention / Treatment: Procedure: Robot-assisted Invasion-controlled Surgery; Procedure: Traditional-open Surgery

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: wei Xu, profession; Phone Number: 86-21-81885045 13761278657; Email: xuweichangzheng@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Changzheng hospital
      • Contact: pengru Wang; Phone Number: 18516609786; Email: wprynl@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted Invasion-controlled Surgery	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.
Placebo Comparator: Traditional-open Surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative bleeding	It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	Is the time from the beginning of the operation to the end of the incision suture is the total operation time	Intraoperative
Intraoperative transfusion volume	That is the amount of intraoperative red blood cell suspension and plasma input and the incidence of blood transfusion.	Intraoperative
Intraoperative fluoroscopy dose	The product of intraoperative c-arm fluoroscopy times and single fluoroscopy dose	Intraoperative
VAS Scores	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)	less than 2 years
Frankel Scores	The Frankel Scale for Spinal Cord Injury That Classifies the Extent of the Neurological/Functional Deficit into Five Grades	less than 2 years
Creatine kinase levels	reatine kinase were examined 1 day after operation	less than 2 years
myoglobin	myoglobin were examined 1 day after operation	less than 2 years
Complications	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	less than 2 years
QOL Scores	Quality of life (QOL) is a multidimensional concept that measures a person's wellbeing.	less than 2 years
resuming time of daily life	Time spent in bed after surgery was recorded	less than 2 years
Survival time	Survival time	less than 2 years
ODI scores	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.	less than 2 years

Collaborators and Investigators

• Sponsor: WEI XU
• Investigators: Study Chair: Jianru Xiao, Profession, Shanghai Changzheng Hospital; Study Director: Wei Xu, Profession, Shanghai Changzheng Hospital; Principal Investigator: Bo Li, Profession, Shanghai Changzheng Hospital; Principal Investigator: Pengru Wang, Profession, Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 25, 2021
• Primary Completion (Anticipated): December 10, 2022
• Study Completion (Anticipated): December 10, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: December 25, 2021
• First Posted (Actual): December 30, 2021

Study Record Updates

• Last Update Posted (Actual): December 30, 2021
• Last Update Submitted That Met QC Criteria: December 25, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Robot-assisted; Spinal Metastases; Minimal surgery; invsasion-controlled surgery; traditional-open surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 2021SL046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No