Clinical Trial: Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis

Brief Summary: To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).

Detailed Summary:

Mitomycin C (MMC) is an antineoplastic agent that inhibits the synthesis of DNA, cellular RNA, and protein by inhibiting the synthesis of collagen by fibroblasts. MMC was originally used as a systemic chemotherapeutic agent, it has been widely used in ophthalmic practice both intraoperatively and postoperatively for prevention of pterygium recurrence, enhancing the success rate of glaucoma filtration surgery. Recently, use of MMC has been described in lacrimal drainage surgery. It is postulated that adjunctive use of MMC over the osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR)surgery could inhibit scarring and granulation tissue formation around the osteotomy site or common canaliculus and enhance the success of EN-DCR surgery.

Many controlled trials have investigated adjunctive MMC for primary or revision EN-DCR to augment the surgical success rate, but the results are not completely consistent. To the best of our knowledge, there was no meta-analysis on comparison of success rate of EN-DCR with MMC (MMC group) and endoscopic dacryocystorhinostomy without MMC (control group). Therefore, the aim of this study was to undertake systematic review and meta-analysis to evaluate the efficacy of intraoperative MMC application in EN-DCR surgery and help ophthalmologists to determine whether it is a useful adjuvant in EN-DCR surgery.


Sponsor: Yifan Feng

Current Primary Outcome: success rate [ Time Frame: 6 months ]

Success was determined by the presence of any one of the following: (1) patent lacrimal passage on syringing, (2) symptomatic improvement, and (3) endoscopic visualisation of fluorescein dye at the nasal opening of the anastomoses.


Original Primary Outcome: Same as current

Current Secondary Outcome: ostium size [ Time Frame: 12 months ]

Change of ostium size at 3-, 6- and 12-month postoperatively


Original Secondary Outcome: Same as current

Information By: Wenzhou Medical University

Dates:
Date Received: January 16, 2013
Date Started: December 2012
Date Completion:
Last Updated: February 12, 2014
Last Verified: February 2014