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In our study, a multicenter randomized controlled，single blind trial will be performed to evaluate the effectiveness and safety of these three procedures for the treatment of symptomatic lumbar disc herniation.
Lumbar disc herniation (LDH) is one of the most common diseases in the department of orthopedics, which produced medical and economic burdens to families and society. In spite, the majority of the patients with disc herniation can be relieved or even cured via conservative treatment; there are still a considerable number of invalid patients who eventually still need to be undergoing a surgical operation treatment. Three main methods for intervertebral disc surgery are adopted in our routine work. One procedure is Open Discectomy (OD), which has been always a gold standard for treatment of LDH. And the other two procedures are Microendoscopic Discectomy (MED) and Transforaminal Endoscopic Lumbar Discectomy (TELD) respectively. MED and TELD have been developed as alternatives to OD. OD can compress the nerve root or spinal cord through removal of the protrusion. However, it destroys the rear structure of spine, causing segmental instability and long-term distress. Compared with OD, MED and TELD procedures are smaller incisions or less dissection (or both), lower blood loss, less postoperative pain, shorter hospitalisation and earlier return to work. However, the steep learning curves of MID inhibit the development of surgery specialists; for example, optimal surgical management requires many years of experience. These deficiencies need more educational effort at a higher priority than accorded so far. There are inconsistent outcomes about the efficacy and safety in the previous studies; all of the recent researches do not yield conclusive results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open discectomy | Active Comparator | patients diagnosed as lumbar disc herniation undergoing open simple discectomy(OD) |
|
| microendoscopic discectomy | Active Comparator | patients diagnosed as lumbar disc herniation undergoing microendoscopic discectomy(MED) |
|
| transforaminal endoscopic discectomy | Active Comparator | patients diagnosed as lumbar disc herniation undergoing transforaminal endoscopic lumbar discectomy(TELD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open discectomy | Procedure | The open discectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision. |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index(ODI) | Oswestry Disability Index (ODI) -> The Oswestry Disability Index (ODI) is one of the principal condition-specific outcome measures used in the management of spinal disorders. The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst The ODI is the most commonly outcome measures in patients with low back pain. Each of the 10 items is scored from 0 - 5. The maximum score is therefore 50. If the FIRST statement is marked, the section score = 0, If the LAST statement is marked, it = 5. 0 is the best outcome and 50 is the worst outcome | up to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale(VAS) | Pain Score - Visual Analog Scale (VAS) -> minimum value=0 and maximum value=10, higher values represent a worse outcome and zero is a better outcome | up to 104 weeks |
| The generic health survey on the Short Form-36(SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wang Kun, PHD | Contact | +86(25)-83262331 | wangkunspine@163.com | |
| Wu Xiaotao, MD | Contact | +86(25)-83262331 | wuxiaotao@medmail.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wu Xiaotao, MD | Zhangda hospital,Southeast university | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19830485 | Result | Liu WG, Wu XT, Guo JH, Zhuang SY, Teng GJ. Long-term outcomes of patients with lumbar disc herniation treated with percutaneous discectomy: comparative study with microendoscopic discectomy. Cardiovasc Intervent Radiol. 2010 Aug;33(4):780-6. doi: 10.1007/s00270-009-9720-6. Epub 2009 Oct 15. | |
| 17077737 | Result | Wu X, Zhuang S, Mao Z, Chen H. Microendoscopic discectomy for lumbar disc herniation: surgical technique and outcome in 873 consecutive cases. Spine (Phila Pa 1976). 2006 Nov 1;31(23):2689-94. doi: 10.1097/01.brs.0000244615.43199.07. |
| Label | URL |
|---|---|
| The North American Spine Society | View source |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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|
| microendoscopic discectomy | Procedure | Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis. |
|
| transforaminal endoscopic lumbar discectomy | Procedure | transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen |
|
The scale was used to evaluate the quality of life
| up to 104 weeks |
| Complications survey | Complications of surgery including mortality and common: thrombosis; surgical site and other infections; recurrent disc herniation; dural tear; nerve root injury | up to 104 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |