Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
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Purpose
To assess the efficacy and safety of local application of intraoperative mitomycin C (MMC) at osteotomy site in endoscopic dacryocystorhinostomy(EN-DCR).
| Condition |
|---|
|
Dacryocystitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Retrospective |
| Official Title: | Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis |
- success rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Change of ostium size at 3-, 6- and 12-month postoperatively
| Estimated Enrollment: | 400 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
MMC group
patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC
|
|
Control group
patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with and without MMC
Inclusion Criteria:
- comparative studies;
- adult patients (> 18 years) with NLDO undergoing primary or revision EN-DCR;
- 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:
- studies which did not provide the success rates;
- studies which included pediatric cases.
Contacts and Locations| Contact: Yifan Feng, PhD | +86-577-88068880 | wzafengyifan@163.com |
| China, Zhejiang | |
| Wenzhou Medical College | Recruiting |
| Wenzhou, Zhejiang, China, 325000 | |
| Contact: Yifan Feng, PhD +86-577-88068880 wzafengyifan@163.com | |
| Principal Investigator: Yifan Feng, PhD | |
| Principal Investigator: | Shiming Cheng, MD | Eye Hospital, Wenzhou Medical College, China |
More Information
No publications provided
| Responsible Party: | Yifan Feng, Eye Hospital, Wenzhou Medical College, China, Wenzhou Medical College |
| ClinicalTrials.gov Identifier: | NCT01772277 History of Changes |
| Other Study ID Numbers: | F20130115 |
| Study First Received: | January 16, 2013 |
| Last Updated: | January 18, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Wenzhou Medical College:
|
Endoscopic dacryocystorhinostomy Mitomycin C |
Additional relevant MeSH terms:
|
Dacryocystitis Lacrimal Apparatus Diseases Eye Diseases Mitomycins Mitomycin Antibiotics, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents |
ClinicalTrials.gov processed this record on May 23, 2013