An interventional study of Trans-Quadrant Channel Surgery and Conventional Open Surgery in Spinal Neoplasms, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Not applicable, Interventional, and Treatment
Intra-spinal canal tumors are the general term of primary tumors from spinal cord or various tissues in the spinal canal and adjacent to the spinal cord, while the metastatic tumors are those from other sites other than spinal canal. Intra-spinal canal tumor is one of the most common diseases in neurosurgery, and surgery is the most effective treatment. Conventional open surgery is required to remove the posterior structures of the spine, which would lead to fracture of the posterior tension band, soft tissue injury, spine instability, and even spine deformity. So it is very important to protect and rebuild the posterior tension band for the stability of the spine. The team of Dr. John P. Kostuik from the Department of Orthopedics and Neurosurgery, the Johns Hopkins University, firstly introduced minimally invasive surgery for cervical and lumbar degenerative disease. However it has not been applied to the treatment of intra-spinal canal tumors. To date, the microsurgery of intra-spinal tumor through the trans-Quadrant channel pathway has not been widely performed in clinical practice. The investigators performed the microsurgery of intra-spinal canal tumor through the trans-Quadrant pathway in some patients previously and succeeded in the surgical treatments. The investigators analyzed the clinical data retrospectively, including surgical incision length, the volume of bleeding during operation, post-operative drainage volume, post-operative out-of-bed time point, post-operative length of stay in hospital, and post-operative visual analog pain (VAP) score. The group of patients using microsurgical technique through trans-Quadrant channel pathway showed better outcome compared with the group of patients using conventional open surgery. This innovation of microsurgery showed fewer traumas and bleeding, more rapid recovery, better prognosis and more safety in practice. Since there are some limitations to the retrospective study, it is necessary to design a prospective randomized controlled trial of the treatment of intra-spinal canal tumors using microsurgical technique through trans-Quadrant channel pathway.
This study is the prospective randomized controlled clinical trial.
18 studies on the registry are indexed under Spinal Neoplasms; 5 are open to participants now.
This study's planned enrollment of 58 is below the median of 71 across 11 interventional studies indexed under Spinal Neoplasms.
Browse Spinal Neoplasms studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 314 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the experimental arm (experimental group, i.e. microsurgery through trans-Quadrant channel pathway) will be operated using Quadrant channel system. All the tumor resection will be operated through the Quadrant channel with assistance of microsurgical techniques.
Procedure: Trans-Quadrant Channel Surgery
Patients in the active comparator arm (control group, i.e. conventional open surgery) will be operated using the conventional open surgery. All the tumor resection will be operated directly with conventional procedures. More posterior structures of spine will be removed.
Procedure: Conventional Open Surgery
Patients in the experimental group will be general anaesthetized and placed in the prone position. Intra-operational electrophysiological monitoring will be used. Kirschner wire will be used to identify the position of the Quadrant channel with X-ray. After disinfection and draping, an incision of 3cm long and 2-3cm lateral to midline on the tumor side will be made. Soft tissues will be separated. Graded dilators will be used to establish Quadrant channel. Kerrison clamps will be used to expose the very local posterior spinal structures. Vertebral plate will be windowed with power drill to expose dural mater, and tumors will be removed with microsurgical techniques. Hemostasis will be performed after resection. Dural mater will be closed by titanium clips, and close incision by layers.
Patients in the control group will be general anaesthetized during operation and placed in the prone position. Intra-operational electrophysiological monitoring will be used. Surgeons will locate the lesion by X-ray. After disinfection and draping, the midline incision of 7-10 cm and centered by the lesion segment will be made. Soft tissues will be cut and separated to expose posterior structure of spine. The root of spinal process and half of the vertebral plate on tumor side of certain segments will be removed. The dural mater will be opened. Then surgeons will remove tumor with microsurgical techniques. Hemostasis will be precisely performed after resection, and dural mater will be closed by suturing. Incision will be closed by layers. Drainage would be placed if necessary.
Postoperational Length of Stay in Hospital
The duration of hospital stay from the day after operation to the day of discharge.
Time frame: From the day after operation to up to 4 weeks after operation.
Operaion duration
The time duration of operation.
Time frame: On the day of operation.
Operative incision length
The skin incision length of operation.
Time frame: On the day of operation.
Blood loss in operation
The blood lost during operatioin.
Time frame: On the day of the surgery.
Cost of the surgery
The cost of the surgery, including operation cost, blood cost, anesthetic cost, and material cost, etc.
Time frame: On the day of the surgery.
Post-operative drainage volume
The drainage volume of surgery site from postoperation to the 1st day morning after operation.
Time frame: On the 1st day after operation.
Post-operative VAS
The VAS scores on the 7th and 30th days after operation.
Time frame: On the 7th day and 30th day after operation.
The improvement rate of Japanese Orthopaedic Association Scores (JOAS)
Collect the pre-operational JOAS score and the JOAS score on the 1st day after operation.
Time frame: On the 1st day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 7th day after operation.
Time frame: On the 7th day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 30th day after operation.
Time frame: On the 30th day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 90th day after operation.
Time frame: On the 90th day after operation.
The improvement rate of JOAS
Collect the pre-operational JOAS score and the JOAS score on the 180th day after operation.
Time frame: On the 180th day after operation.
Plan to share: No
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This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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