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

Dacryocystitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01772277
• Other study ID #: F20130115
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: February 12, 2014
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Dacryocystitis

Locations

Country	Name	City	State
China	Wenzhou Medical College	Wenzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Yifan Feng	Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	success rate	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.	6 months	Yes
Secondary	ostium size	Change of ostium size at 3-, 6- and 12-month postoperatively	12 months	Yes