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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01772277
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : February 13, 2014
Wenzhou Medical University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical University

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

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.

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Study Type : Observational
Estimated 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 : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

MMC group
patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC
Control group
patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. ostium size [ Time Frame: 12 months ]
    Change of ostium size at 3-, 6- and 12-month postoperatively

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with and without MMC

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772277

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China, Zhejiang
Wenzhou Medical College
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Yifan Feng
Wenzhou Medical University
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Principal Investigator: Shiming Cheng, MD Eye Hospital, Wenzhou Medical College, China

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yifan Feng, Eye Hospital, Wenzhou Medical College, China, Wenzhou Medical University Identifier: NCT01772277    
Other Study ID Numbers: F20130115
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Yifan Feng, Wenzhou Medical University:
Endoscopic dacryocystorhinostomy
Mitomycin C
Additional relevant MeSH terms:
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Lacrimal Apparatus Diseases
Eye Diseases
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors