NCT01772277

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 21, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 13, 2014

Status Verified

February 1, 2014

Enrollment Period

1.2 years

First QC Date

January 16, 2013

Last Update Submit

February 12, 2014

Conditions

Dacryocystitis

Keywords

Endoscopic dacryocystorhinostomyMitomycin C

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • ostium size

    12 months

Study Arms (2)

MMC group

patients were scheduled to undergo Endoscopic dacryocystorhinostomy with intraoperative MMC

Control group

patients were scheduled to undergo Endoscopic dacryocystorhinostomy without intraoperative MMC

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • comparative studies;
  • adult patients (\> 18 years) with NLDO undergoing primary or revision EN-DCR;
  • 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.

You may not qualify if:

  • studies which did not provide the success rates;
  • studies which included pediatric cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wenzhou Medical College

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

  • 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.

    PMID: 23675423DERIVED

MeSH Terms

Conditions

Dacryocystitis

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Shiming Cheng, MD

    Eye Hospital, Wenzhou Medical College, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Eye Hospital, Wenzhou Medical College, China

Study Record Dates

First Submitted

January 16, 2013

First Posted

January 21, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 13, 2014

Record last verified: 2014-02

Locations

CN(1)