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

Sponsor
Yifan Feng (Other)
Overall Status
Completed
CT.gov ID
NCT01772277
Collaborator
Wenzhou Medical University (Other)
400
Enrollment
1
Location
14
Duration (Months)
28.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Efficacy of Mitomycin C in Endoscopic Dacryocystorhinostomy: A Systematic Review and Meta-Analysis
    Study Start Date :
    Dec 1, 2012
    Actual Primary Completion Date :
    Feb 1, 2014
    Actual Study Completion Date :
    Feb 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    MMC group

    patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC
    Control group

    patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC

    Outcome Measures

    Primary Outcome Measures

    1. success rate [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.

    Secondary Outcome Measures

    1. ostium size [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wenzhou Medical College Wenzhou Zhejiang China 325000

    Sponsors and Collaborators

    • Yifan Feng
    • Wenzhou Medical University

    Investigators

    • Principal Investigator: Shiming Cheng, MD, Eye Hospital, Wenzhou Medical College, China

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yifan Feng, Eye Hospital, Wenzhou Medical College, China, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT01772277
    Other Study ID Numbers:
    • F20130115
    First Posted:
    Jan 21, 2013
    Last Update Posted:
    Feb 13, 2014
    Last Verified:
    Feb 1, 2014
    Keywords provided by Yifan Feng, Eye Hospital, Wenzhou Medical College, China, Wenzhou Medical University
    Endoscopic dacryocystorhinostomy
    Mitomycin C
    Additional relevant MeSH terms:
    Dacryocystitis

    Study Results

    No Results Posted as of Feb 13, 2014