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Mitomycin C effects on epidural fibrosis in microendoscopic discectomy
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August 2013
Mitomycin C effects on epidural fibrosis in microendoscopic discectomy
Study Type:Therapy
OE Level Evidence:1
Journal Level of Evidence:N/A
Inhibition of epidural fibrosis after microendoscopic discectomy with topical application of mitomycin C: a randomized, controlled, double-blind trial
J Neurosurg Spine. 2013 May;18(5):421-7. doi: 10.3171/2013.1.SPINE12564. Epub 2013 Mar 8Did you know you're eligible to earn 0.5 CME credits for reading this report? Click Here
Synopsis
75 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.
Publication Funding Details
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Funding:
Non-Industry funded
Sponsor:
National Natural Science Foundation of China (Grant Nos. 30973058 and 81171694); the Program for Development of Innovative Research Team in the First Affiliated Hospital of NJMU (No. IRT-015); and a project funded by the Priority Academic Program Development of Jiangsu Higher Education Institutions
Conflicts:
None disclosed
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)?
Yes = 1
Uncertain = 0.5
Not Relevant = 0
No = 0
The Reporting Criteria Assessment evaluates the transparency with which authors report the methodological and trial characteristics of the trial within the publication. The assessment is divided into five categories which are presented below.
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
The Fragility Index is a tool that aids in the interpretation of significant findings, providing a measure of strength for a result. The Fragility Index represents the number of consecutive events that need to be added to a dichotomous outcome to make the finding no longer significant. A small number represents a weaker finding and a large number represents a stronger finding.
Why was this study needed now?
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.
What was the principal research question?
What are the effects and safety of locally applied mitomycin C (MMC) on epidural fibrosis after microendoscopic discectomy?
Study Characteristics
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Population:
75 patients undergoing single level unilateral microendoscopic discectomy for lumbar disc herniation
Intervention:
MMC Group: Patients received cotton wool impregnated with 0.5 mg/ml MMC applied on site of discectomy for 5 minutes. Mean age = 35.67 +/-10.66 years, M/F=23/9 (n=37)
Comparison:
Control Group: Patients received cotton wool with saline, applied on site of discectomy for 5 minutes. Mean age = 35.00 +/- 9.95 years, M/F= 20/10 (n=38)
Outcomes:
Clinical outcomes measured by Lumbar Surgery Outcomes Questionnaire (LSOQ) and neurological examinations. Radiological evaluations were measured by MRI images, according to The Ross Grading System and Modified Grading System.
Methods:
RCT; Double Blind; Single Center
Time:
6 months (assessments at 7 days, 3 months, and 6 months)
What were the important findings?
- 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.
What should I remember most?
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.
How will this affect the care of my patients?
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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