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| Name | Class |
|---|---|
| The First Hospital of Hebei Medical University | OTHER |
| Beijing Jiangong Hospital | UNKNOWN |
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The purpose of this study is to determine whether a posterior fossa decompression and duraplasty with or without tonsil manipulation results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.
Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression and duraplasty with or without tonsil manipulation. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: 3-6 months, 12 and 24 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete questionnaires. A spine MRI will be performed 3-6 months, 12 and 24 months after the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Posterior fossa decompression with duraplasty | Experimental | In brief, a midline incision was made from the inion to the C2 level. A piece of autologous fascia was harvested from the muscular fascia layer. Paraspinal muscles were dissected to expose the occipital bone, posterior arch of the atlas and axis, spinous process, and lamina. The inferior portion of the occipital bone and approximately 2 cm of the posterior arch of C1 were removed, achieving bony decompression (approximately 2.5-3 × 2.5-3 cm). Once the dura was exposed, the atlanto-occipital membrane was coagulated and dissected off the dura. The dura was then incised in a Y-shaped fashion, with care taken to preserve the underlying arachnoid. Watertight duraplasty was performed using the autologous fascia. The wound was closed in anatomical layers. |
|
| PFDD with tonsillar resection/reduction | Experimental | Briefly, a midline incision approximately 3-4 cm posterior to the foramen magnum is made. The incision is deepened layer by layer along the midline to reach the occipital bone, exposing the posterior margin of the foramen magnum and part of the occipital squama. The posterior edge of the foramen magnum is opened, and part of the occipital squama is removed up to the junction of the cerebellar vermis and cerebellar tonsils. The occipitoatlantal fascia is exposed and dissected. The dura mater and arachnoid mater are incised longitudinally and suspended bilaterally to provide a clear surgical field. The primary objectives of resection were: ensuring no significant obstruction of CSF circulation at the foramen magnum and the foramen of Magendie under natural conditions. Preventing occlusion of the foramen of Magendie caused by herniated cerebellar tonsils or any membranous structures under natural conditions. The dura is closed in situ. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior fossa decompression with duraplasty | Procedure | In brief, a midline incision was made from the inion to the C2 level. A piece of autologous fascia was harvested from the muscular fascia layer. Paraspinal muscles were dissected to expose the occipital bone, posterior arch of the atlas and axis, spinous process, and lamina. The inferior portion of the occipital bone and approximately 2 cm of the posterior arch of C1 were removed, achieving bony decompression (approximately 2.5-3 × 2.5-3 cm). Once the dura was exposed, the atlanto-occipital membrane was coagulated and dissected off the dura. The dura was then incised in a Y-shaped fashion, with care taken to preserve the underlying arachnoid. Watertight duraplasty was performed using the autologous fascia. The wound was closed in anatomical layers. |
| Measure | Description | Time Frame |
|---|---|---|
| improvement or resolution of the syrinx, | defined as > 50% improvement in length, maximal cross-sectional diameter, or both. | 3-6, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| complication rates | Reoperation,Wound infection,Aseptic meningitis,CSF fistula,Subcutaneous hydrops,Other complications | 12 months |
| Chicago Chiari Outcome Scale (CCOS) scale | for evaluating the spinal cord function after chiari decompression surgery, Each item is scored on a scale from 1 to 4, with 4 representing the best possible functional status. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| fengzeng jian | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fengzeng Jian | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32114543 | Background | Hale AT, Adelson PD, Albert GW, Aldana PR, Alden TD, Anderson RCE, Bauer DF, Bonfield CM, Brockmeyer DL, Chern JJ, Couture DE, Daniels DJ, Durham SR, Ellenbogen RG, Eskandari R, George TM, Grant GA, Graupman PC, Greene S, Greenfield JP, Gross NL, Guillaume DJ, Heuer GG, Iantosca M, Iskandar BJ, Jackson EM, Johnston JM, Keating RF, Leonard JR, Maher CO, Mangano FT, McComb JG, Meehan T, Menezes AH, O'Neill B, Olavarria G, Park TS, Ragheb J, Selden NR, Shah MN, Smyth MD, Stone SSD, Strahle JM, Wait SD, Wellons JC, Whitehead WE, Shannon CN, Limbrick DD; Park-Reeves Syringomyelia Research Consortium Investigators. Factors associated with syrinx size in pediatric patients treated for Chiari malformation type I and syringomyelia: a study from the Park-Reeves Syringomyelia Research Consortium. J Neurosurg Pediatr. 2020 Mar 6;25(6):629-639. doi: 10.3171/2020.1.PEDS19493. Print 2020 Jun 1. | |
| 35652180 |
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| ID | Term |
|---|---|
| D001139 | Arnold-Chiari Malformation |
| D013595 | Syringomyelia |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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|
| PFDD with tonsillar resection/reduction | Procedure | Briefly, a midline incision approximately 3-4 cm posterior to the foramen magnum is made. The incision is deepened layer by layer along the midline to reach the occipital bone, exposing the posterior margin of the foramen magnum and part of the occipital squama. The posterior edge of the foramen magnum is opened, and part of the occipital squama is removed up to the junction of the cerebellar vermis and cerebellar tonsils. The occipitoatlantal fascia is exposed and dissected. The dura mater and arachnoid mater are incised longitudinally and suspended bilaterally to provide a clear surgical field. The primary objectives of resection were: ensuring no significant obstruction of CSF circulation at the foramen magnum and the foramen of Magendie under natural conditions. Preventing occlusion of the foramen of Magendie caused by herniated cerebellar tonsils or any membranous structures under natural conditions. The dura is closed in situ. |
|
| 12 months |
| visual analog scale (VAS) | degree of the pain, 1-10, higher scores mean a worse outcome | 12 months |
| Japanese Orthopaedic Association (JOA) scale | Motor function, sensory, bladder function;for evaluating the spinal cord function;0-17, higher scores mean a better outcome | 12 months |
| blood loss | blood loss | 12 months |
| hospital stay | hospital stay | 12 months |
| cost for the hospitalisation. | cost for the hospitalisation. | 12 months |
| Background |
| Yuan C, Wei M, Li W, Wang X, Jian F. Comparison of Foramen Magnum Decompression with and without Duraplasty in the Treatment of Adult Chiari Malformation Type I: A Meta-Analysis and Systematic Review. Turk Neurosurg. 2022;32(6):893-902. doi: 10.5137/1019-5149.JTN.35727-21.5. |
| 32805463 | Background | Guan J, Yuan C, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Intradural Pathology Causing Cerebrospinal Fluid Obstruction in Syringomyelia and Effectiveness of Foramen Magnum and Foramen of Magendie Dredging Treatment. World Neurosurg. 2020 Dec;144:e178-e188. doi: 10.1016/j.wneu.2020.08.068. Epub 2020 Aug 15. |
| 32059967 | Background | Yuan C, Guan J, Du Y, Zhang C, Ma L, Yao Q, Cheng L, Liu Z, Wang K, Duan W, Wang X, Wu H, Chen Z, Jian F. Repeat Craniocervical Decompression in Patients with a Persistent or Worsening Syrinx: A Preliminary Report and Early Results. World Neurosurg. 2020 Jun;138:e95-e105. doi: 10.1016/j.wneu.2020.02.015. Epub 2020 Feb 12. |
| 29618081 | Background | Heiss JD, Jarvis K, Smith RK, Eskioglu E, Gierthmuehlen M, Patronas NJ, Butman JA, Argersinger DP, Lonser RR, Oldfield EH. Origin of Syrinx Fluid in Syringomyelia: A Physiological Study. Neurosurgery. 2019 Feb 1;84(2):457-468. doi: 10.1093/neuros/nyy072. |
| 31628281 | Background | Koueik J, Sandoval-Garcia C, Kestle JRW, Rocque BG, Frim DM, Grant GA, Keating RF, Muh CR, Oakes WJ, Pollack IF, Selden NR, Tubbs RS, Tuite GF, Warf B, Rajamanickam V, Broman AT, Haughton V, Rebsamen S, George TM, Iskandar BJ. Outcomes in children undergoing posterior fossa decompression and duraplasty with and without tonsillar reduction for Chiari malformation type I and syringomyelia: a pilot prospective multicenter cohort study. J Neurosurg Pediatr. 2019 Oct 18;25(1):21-29. doi: 10.3171/2019.8.PEDS19154. Print 2020 Jan 1. |
| 42080534 | Derived | Yuan C, Yuan F, Li K, Ding C, Du Y, Zhang L, Zhang C, Liu Z, Wang K, Duan W, Wang Z, Wang X, Wu H, Chen Z, Jian F, Guan J. Comparison of Foramen Magnum and Foramen of Magendie Dredging Versus Posterior Fossa Decompression With Duraplasty in Adults With Chiari I Malformation-Syringomyelia: A Propensity-Matched Study. Neurosurgery. 2026 May 4. doi: 10.1227/neu.0000000000004061. Online ahead of print. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |