SPINE
Inhibition of epidural fibrosis after microendoscopic discectomy with topical application of mitomycin C: a randomized, controlled, double-blind trial
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(12):221 J Neurosurg Spine. 2013 May;18(5):421-7. doi: 10.3171/2013.1.SPINE12564. Epub 2013 Mar 875 patients undergoing single level unilateral microendoscopic discectomy for lumbar disc herniation were randomized to either receive a cotton wool impregnated with 0.5mg/ml of mitomycin C (MMC) or saline at the surgical site for discectomy. The 6 month results, studying the effects of MMC on preventing epidural fibrosis, showed no differences in clinical and neurological assessments between the two groups. Radiographic evaluations, however, according to Ross Grading and modified grading system indicated decreased epidural fibrosis with MMC.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomização
3/4
Medidas de resultado
2/4
Inclusão/Exclusão
4/4
Descrição do tratamento
3/4
Estatística
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Epidural fibrosis, postoperative scar tissue formation around the nerve roots, is one of the main causes of pain and undesirable postoperative symptoms following spinal surgery. Epidural adhesions are also known to increase the risk of nerve root injury and dural tears. Previous studies have shown that anti-adhesion agents, such as mitomycin C, can minimize postoperative scarring in animals, but trials on humans have been unsuccessful. Hence, this study aimed to investigate the effects of epidural fibrosis after lumbar microendoscopic discectomy.
主な研究課題は何ですか？
What are the effects and safety of locally applied mitomycin C (MMC) on epidural fibrosis after microendoscopic discectomy?
重要な知見は？
- MMC and Control groups did not display significant differences in LSOQ scores and neurological examinations at 7 days, 3 months, and 6 months (P>0.05)
- MRI evaluation according to Ross Grading System showed more frequent grade 3 and 4 scars in MMC group than in the control group (24.7% vs. 12.2%) (p<0.05)
- MRI results by Modified Grading System showed “excellent” intra-rater agreement, and significant differences favoring MMC in average CSA (cross sectional area) of epidural scar (p=0.014) and epidural fibrosis index (p=0.021). Mean cross-sectional areas of epidural fibrosis were 7.32-70.06 mm2 in the MMC group and 22.94-90.48 mm2 in the control group. The epidural fibrosis index ranged from 0.0296 to 0.3267 in the MMC group and from 0.1191 to 0.3483 in the control group.
- No wound infections or delays, dural tears, spinal epidural hematomas, or arachnoiditis occurred through the study.
最も覚えておくべきことは？
Although MMC use presented no clinically different results in LSOQ and neurological questionnaires, it resulted in significantly smaller epidural fibrosis index, indicating MMC's efficacy in reducing epidural fibrosis.
それが私の患者ケアにどのように影響するか？
Results suggested that 0.5 mg/ml of mitomycin C is safe and effective in the prevention of epidural fibrosis after microendoscopic discectomy, when no dural tears are present. Further multicenter studies are required to study mitomycin C use in semilaminectomy.
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