Clinical trial NCT01772277: Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
Official title: Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dacryocystitis
Keywords: Endoscopic dacryocystorhinostomy
Mitomycin C
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
Collaborators: name: Wenzhou Medical University
First posted: 2013-01-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with and without MMC

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. comparative studies;
2. adult patients (\> 18 years) with NLDO undergoing primary or revision EN-DCR;
3. all studies included were required to provide the success rates of both MMC and control groups, and the followed up time was more than 6 months.

Exclusion Criteria:

1. studies which did not provide the success rates;
2. studies which included pediatric cases.

Primary outcomes:
measure: success rate
timeFrame: 6 months
Secondary outcomes:
measure: ostium size
timeFrame: 12 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Shiming Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng SM, Feng YF, Xu L, Li Y, Huang JH. Efficacy of mitomycin C in endoscopic dacryocystorhinostomy: a systematic review and meta-analysis. PLoS One. 2013 May 13;8(5):e62737. doi: 10.1371/journal.pone.0062737. Print 2013.