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

NCT ID: NCT01772277

Last Updated: 2014-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Dacryocystitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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MMC group

patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC

No interventions assigned to this group

Control group

patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role collaborator

Yifan Feng

OTHER

Sponsor Role lead

Responsible Party

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Yifan Feng

Eye Hospital, Wenzhou Medical College, China

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shiming Cheng, MD

Role: PRINCIPAL_INVESTIGATOR

Eye Hospital, Wenzhou Medical College, China

Locations

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Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 23675423 (View on PubMed)

Other Identifiers

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F20130115

Identifier Type: -

Identifier Source: org_study_id

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