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)?
Sì = 1
Incerto = 0,5
Non rilevante = 0
No = 0
La valutazione dei criteri di segnalazione valuta la trasparenza con cui gli autori riportano le caratteristiche metodologiche e sperimentali dello studio all'interno della pubblicazione. La valutazione è suddivisa in cinque categorie che vengono presentate di seguito.
4/4
Randomization
3/4
Outcome Measurements
2/4
Inclusion / Exclusion
4/4
Therapy Description
3/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
L'Indice di Fragilità è uno strumento che aiuta l'interpretazione dei risultati significativi, fornendo una misura della forza di un risultato. L'Indice di Fragilità rappresenta il numero di eventi consecutivi che devono essere aggiunti a un risultato dicotomico per rendere il risultato non più significativo. Un numero piccolo rappresenta un risultato più debole, mentre un numero grande rappresenta un risultato più forte.
Perché questo studio era necessario ora?
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.
Qual era la domanda di ricerca principale?
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.
Che cosa devo ricordare di più?
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.
Come influenzerà l'assistenza ai miei pazienti?
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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