Mitomycin C effects on epidural fibrosis in microendoscopic discectomy .
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)?
Sí = 1
Incierto = 0,5
No relevante = 0
No = 0
La evaluación de los criterios de información evalúa la transparencia con la que los autores informan de las características metodológicas y del ensayo dentro de la publicación. La evaluación se divide en cinco categorías que se presentan a continuación.
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Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
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Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
El Índice de Fragilidad es una herramienta que ayuda en la interpretación de hallazgos significativos, proporcionando una medida de fuerza para un resultado. El Índice de Fragilidad representa el número de eventos consecutivos que es necesario añadir a un resultado dicotómico para que el hallazgo deje de ser significativo. Un número pequeño representa un hallazgo más débil y un número grande un hallazgo más fuerte.
¿Por qué se necesitaba ahora este estudio?
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.
¿Cuál era la pregunta principal de la investigación?
What are the effects and safety of locally applied mitomycin C (MMC) on epidural fibrosis after microendoscopic discectomy?
- 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.
¿Qué es lo que más debo recordar?
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.
¿Cómo afectará esto al cuidado de mis pacientes?
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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