TY - JOUR
A1 - Sui, Tao
A1 - Liu, Lei
A1 - Wu, Xiao-tao
A1 - Cao, Xiao-jian
T1 - Local application of mitomycin C for prevention of epidural fibrosis: study protocol for a prospective randomized controlled double-blinded trial
Y1 - 2016/1/1
JF - Clinical Trials in Orthopedic Disorders
JO - Clin Trials Orthop Disord
SP - 22
EP - 30
VL - 1
IS - 1
UR - https://www.clinicalto.com/article.asp?issn=2542-4157;year=2016;volume=1;issue=1;spage=22;epage=30;aulast=Sui
DO - 10.4103/2468-5674.178847
N2 - 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.
ER -