Minimally Invasive SurgeryNCT05173467
Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
A study testing Traditional-open Surgery in people with Minimally Invasive Surgery and Spinal Metastases, run by Wei Xu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Minimally Invasive Surgery, Spinal Metastases
- What is being tested?
- Traditional-open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2021to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
ChangZheng Hospital
Shanghai, Shanghai Municipality, 200001
pengru Wang, 18516609786, wprynl@163.com
About this study
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.
Read the 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.
- Conditions
- Minimally Invasive Surgery, Spinal Metastases
- Being tested
- Robot-assisted Invasion-controlled Surgery, Traditional-open Surgery
- Keywords
- Minimal surgery, Spinal Metastases, invsasion-controlled surgery, traditional-open surgery, Robot-assisted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted Invasion-controlled SurgeryProcedure or 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.
Traditional-open SurgeryProcedure or surgery
This traditionally requires a midline incision, bilateral muscle strip, and multilevel laminectomy to provide adequate access and safe removal of the tumor.
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Invasion-controlled Surgery | Experimental | Not described Receives: Procedure: Robot-assisted Invasion-controlled Surgery |
| Traditional-open Surgery | Placebo comparator | Not described Receives: Procedure: Traditional-open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative bleeding
It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.
Measured: Intraoperative
Secondary outcomes (12)
operation time
Is the time from the beginning of the operation to the end of the incision suture is the total operation time
Measured: Intraoperative
Intraoperative transfusion volume
That is the amount of intraoperative red blood cell suspension and plasma input and the incidence of blood transfusion.
Measured: Intraoperative
Intraoperative fluoroscopy dose
The product of intraoperative c-arm fluoroscopy times and single fluoroscopy dose
Measured: 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)
Measured: 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
Measured: less than 2 years
Creatine kinase levels
reatine kinase were examined 1 day after operation
Measured: less than 2 years
myoglobin
myoglobin were examined 1 day after operation
Measured: 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
Measured: less than 2 years
QOL Scores
Quality of life (QOL) is a multidimensional concept that measures a person's wellbeing.
Measured: less than 2 years
resuming time of daily life
Time spent in bed after surgery was recorded
Measured: less than 2 years
Survival time
Survival time
Measured: 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.
Measured: less than 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start25 Dec 2021 (estimated)
- Primary completion10 Dec 2022 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minimally Invasive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Xu, Shanghai Changzheng Hospital
- Investigators
- Jianru Xiao, Profession, Study chair, Shanghai Changzheng HospitalWei Xu, Profession, Study director, Shanghai Changzheng HospitalBo Li, Profession, Principal investigator, Shanghai Changzheng HospitalPengru Wang, Profession, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173467
- Sponsor's protocol ID
- 2021SL046
- Status last verified
- Dec 2021
- First submitted
- 13 Dec 2021
- Last updated
- 30 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Invasion-controlled Surgery Versus Traditional-open Surgery Against Metastatic Spinal Tumor
- ClinicalTrials.gov ID
- NCT05173467
- Acronym / sponsor ID
- 2021SL046
- Conditions
- Minimally Invasive Surgery, Spinal Metastases
- Keywords
- Minimal surgery, Spinal Metastases, invsasion-controlled surgery, traditional-open surgery, Robot-assisted
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wei XuUniversity, hospital or other
- Study start
- 25 Dec 2021 (estimated)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-assisted Invasion-controlled Surgery | Experimental | Procedure: Robot-assisted Invasion-controlled Surgery |
| Traditional-open Surgery | Placebo comparator | Procedure: Traditional-open Surgery |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-assisted Invasion-controlled SurgeryThe 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 or surgery | Robot-assisted Invasion-controlled Surgery |
| Traditional-open SurgeryThis traditionally requires a midline incision, bilateral muscle strip, and multilevel laminectomy to provide adequate access and safe removal of the tumor. | Procedure or surgery | Traditional-open Surgery |
Primary outcome
operative bleeding
Time frame: Intraoperative
It is amount of blood lost during surgery, which is checked by the anesthesiologist and the surgical nurse.
12 secondary outcomes
operation time
Time frame: Intraoperative
Intraoperative transfusion volume
Time frame: Intraoperative
Intraoperative fluoroscopy dose
Time frame: Intraoperative
VAS Scores
Time frame: less than 2 years
Frankel Scores
Time frame: less than 2 years
Creatine kinase levels
Time frame: less than 2 years
myoglobin
Time frame: less than 2 years
Complications
Time frame: less than 2 years
QOL Scores
Time frame: less than 2 years
resuming time of daily life
Time frame: less than 2 years
Survival time
Time frame: less than 2 years
ODI scores
Time frame: less than 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianru Xiao, Profession study chair
Shanghai Changzheng Hospital
Wei Xu, Profession study director
Shanghai Changzheng Hospital
Bo Li, Profession principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional-open Surgery in people with Minimally Invasive Surgery and Spinal Metastases, run by Wei Xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wei Xu, profession (13761278657 ext. 86-21-81885045, xuweichangzheng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative bleeding (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.