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

This study has been completed.
Sponsor:
Collaborator:
Wenzhou Medical University
Information provided by (Responsible Party):
Yifan Feng, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT01772277
First received: January 16, 2013
Last updated: February 12, 2014
Last verified: February 2014
  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

Resource links provided by NLM:


Further study details as provided by Wenzhou Medical University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Study Completion Date: February 2014
Primary Completion Date: February 2014 (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
Study Population

Patients were scheduled to undergo endoscopic dacryocystorhinostomy and randomized to with and without MMC

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01772277

Locations
China, Zhejiang
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
  More Information

No publications provided by Wenzhou Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yifan Feng, Eye Hospital, Wenzhou Medical College, China, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT01772277     History of Changes
Other Study ID Numbers: F20130115
Study First Received: January 16, 2013
Last Updated: February 12, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Wenzhou Medical University:
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 July 28, 2014