Back to resultsRobot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
Primary Purpose
Minimally Invasive Surgery, Spinal Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robot-assisted Invasion-controlled Surgery
Traditional-open Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Minimally Invasive Surgery focused on measuring Minimal surgery, Spinal Metastases, invsasion-controlled surgery, traditional-open surgery, Robot-assisted
Eligibility Criteria
Inclusion Criteria:
- 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)
- 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)
- Metastases are located in the thoracic and/or lumbar vertebrae
- The patient's expected survival was longer than 6 months
- 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:
- He had previously operated on the same site
- Spontaneous multiple compression fractures of the spine;
- There is malformed osteitis (Paget's bone disease), osteomalacia, or other metabolic bone disease;
- here were developmental vertebral malformations or vertebral body and pedicle dysplasia in the spinal segment to be treated by surgery
- 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)
- Pregnant or lactating women
- Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment
Sites / Locations
- ChangZheng Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Robot-assisted Invasion-controlled Surgery
Traditional-open Surgery
Arm Description
Outcomes
Primary Outcome Measures
operative bleeding
It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.
Secondary Outcome Measures
operation time
Is the time from the beginning of the operation to the end of the incision suture is the total operation time
Intraoperative transfusion volume
That is the amount of intraoperative red blood cell suspension and plasma input and the incidence of blood transfusion.
Intraoperative fluoroscopy dose
The product of intraoperative c-arm fluoroscopy times and single fluoroscopy dose
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)
Frankel Scores
The Frankel Scale for Spinal Cord Injury That Classifies the Extent of the Neurological/Functional Deficit into Five Grades
Creatine kinase levels
reatine kinase were examined 1 day after operation
myoglobin
myoglobin were examined 1 day after operation
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
QOL Scores
Quality of life (QOL) is a multidimensional concept that measures a person's wellbeing.
resuming time of daily life
Time spent in bed after surgery was recorded
Survival time
Survival time
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05173467
Brief Title
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
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 25, 2021 (Anticipated)
Primary Completion Date
December 10, 2022 (Anticipated)
Study Completion Date
December 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Minimally Invasive Surgery, Spinal Metastases
Keywords
Minimal surgery, Spinal Metastases, invsasion-controlled surgery, traditional-open surgery, Robot-assisted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot-assisted Invasion-controlled Surgery
Arm Type
Experimental
Arm Title
Traditional-open Surgery
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted Invasion-controlled Surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Traditional-open Surgery
Intervention Description
This traditionally requires a midline incision, bilateral muscle strip, and multilevel laminectomy to provide adequate access and safe removal of the tumor.
Primary Outcome Measure Information:
Title
operative bleeding
Description
It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
operation time
Description
Is the time from the beginning of the operation to the end of the incision suture is the total operation time
Time Frame
Intraoperative
Title
Intraoperative transfusion volume
Description
That is the amount of intraoperative red blood cell suspension and plasma input and the incidence of blood transfusion.
Time Frame
Intraoperative
Title
Intraoperative fluoroscopy dose
Description
The product of intraoperative c-arm fluoroscopy times and single fluoroscopy dose
Time Frame
Intraoperative
Title
VAS Scores
Description
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)
Time Frame
less than 2 years
Title
Frankel Scores
Description
The Frankel Scale for Spinal Cord Injury That Classifies the Extent of the Neurological/Functional Deficit into Five Grades
Time Frame
less than 2 years
Title
Creatine kinase levels
Description
reatine kinase were examined 1 day after operation
Time Frame
less than 2 years
Title
myoglobin
Description
myoglobin were examined 1 day after operation
Time Frame
less than 2 years
Title
Complications
Description
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
Time Frame
less than 2 years
Title
QOL Scores
Description
Quality of life (QOL) is a multidimensional concept that measures a person's wellbeing.
Time Frame
less than 2 years
Title
resuming time of daily life
Description
Time spent in bed after surgery was recorded
Time Frame
less than 2 years
Title
Survival time
Description
Survival time
Time Frame
less than 2 years
Title
ODI scores
Description
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.
Time Frame
less than 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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)
Metastases are located in the thoracic and/or lumbar vertebrae
The patient's expected survival was longer than 6 months
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:
He had previously operated on the same site
Spontaneous multiple compression fractures of the spine;
There is malformed osteitis (Paget's bone disease), osteomalacia, or other metabolic bone disease;
here were developmental vertebral malformations or vertebral body and pedicle dysplasia in the spinal segment to be treated by surgery
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)
Pregnant or lactating women
Participated in clinical trials of other drugs or medical devices within 3 months prior to enrollment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
wei Xu, profession
Phone
13761278657
Ext
86-21-81885045
Email
xuweichangzheng@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianru Xiao, Profession
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wei Xu, Profession
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bo Li, Profession
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pengru Wang, Profession
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
ChangZheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
pengru Wang
Phone
18516609786
Email
wprynl@163.com
12. IPD Sharing Statement
Learn more about this trial
Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
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