Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
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|ClinicalTrials.gov Identifier: NCT01772277|
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : February 13, 2014
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Observational Model:||Case Control|
|Official Title:||Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC
patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC
- 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.
- ostium size [ Time Frame: 12 months ]Change of ostium size at 3-, 6- and 12-month postoperatively
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772277
|Wenzhou Medical College|
|Wenzhou, Zhejiang, China, 325000|
|Principal Investigator:||Shiming Cheng, MD||Eye Hospital, Wenzhou Medical College, China|