• Users Online: 133
  • Home
  • Print this page
  • Email this page
Home About us Editorial board Ahead of print Current issue Search Archives Submit article Instructions Subscribe Contacts Login 
STUDY PROTOCOL
Year : 2016  |  Volume : 1  |  Issue : 1  |  Page : 22-30

Local application of mitomycin C for prevention of epidural fibrosis: study protocol for a prospective randomized controlled double-blinded trial


1 Department of Orthopedics, the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu Province, China
2 Department of Orthopedics, the Affiliated Zhongda Hospital of Southeast University, Nanjing, Jiangsu Province, China
3 Department of Orthopedics, the First Affiliated Hospital of Nanjing Medical University; Department of Orthopedics, the Affiliated Zhongda Hospital of Southeast University, Nanjing, Jiangsu Province, China

Correspondence Address:
Xiao-jian Cao
Department of Orthopedics, the First Affiliated Hospital of Nanjing Medical University; Department of Orthopedics, the Affiliated Zhongda Hospital of Southeast University, Nanjing, Jiangsu Province
China
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2468-5674.178847

Rights and Permissions

Background: Interventions including lumbar discectomy are a primary treatment method for degenerative disc disease. However, after surgery, scar adhesion often forms at the spinal dura mater or adventitial nerves in the defective vertebral plate region and affects recovery. Our previous animal experiments showed that mitomycin C applied topically could safely protect against epidural fibrosis at an optimal dose of 0.5 mg/mL. However, randomized controlled clinical studies have shown that 1 mg/mL mitomycin C does not show obvious therapeutic effects on epidural fibrosis in patients after lumbar discectomy. Methods/Design: This prospective, randomized, controlled, double-blinded, single-center clinical trial will be performed at the Affiliated Zhongda Hospital of Southeast University in China. Seventy-five patients with single-level lumbar disc protrusion will be included in this study and undergo microendoscopic discectomy. The site of discectomy will be topically treated with cotton wool impregnated with 0.5 mg/mL mitomycin C (treatment group) or 0.9% physiological saline (control group) for 5 minutes. Contrast-enhanced MRI score of the lumbar spine will be the primary outcome measure used to evaluate epidural scar proliferation and adhesion, and Lumbar Spine Outcomes Questionnaire score will be the secondary outcome used to evaluate epidural fibrosis-related clinical symptoms. Discussion: This study protocol will try to establish an imaging method to precisely grade epidural fibrosis data acquired after microendoscopic discectomy via a prospective, randomized, controlled, double-blinded trial. A safe and effective mitomycin C dose, 0.5 mg/mL, will be topically applied, and the efficacy and safety of mitomycin C for the prevention of epidural fibrosis will be investigated to provide evidence for the clinical use of mitomycin C. Trial registration: This protocol was registered at Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-10001079) on 6 September 2010. Ethical approval: The study protocol has acquired written approval from Ethics Committee of the First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University, China (approval No. 2010-SR-088) and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed1548    
    Printed152    
    Emailed0    
    PDF Downloaded141    
    Comments [Add]    

Recommend this journal