NCT00571129

Brief Summary

Endoscopic dacryocystorhinostomy (EN-DCR) is an effective procedure when treating saccal and postsaccal obstructions of the nasolacrimal pathway. The benefit of silicone tubing after DCR is still controversial. We conducted a prospective, randomized study in order to evaluate 1) the necessity of bicanalicular silicone tubes after primary EN-DCR, 2) efficacy of the perioperative Mitomycin C for the prevention of adheesion and re-stenosis of rhinostomy site in revision EN-DCR, 3) the subjective symptoms and QoL changes before and after DCR-operation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2004

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

7.3 years

First QC Date

December 10, 2007

Last Update Submit

February 21, 2020

Conditions

Lacrimal Duct Obstruction

Keywords

Primary,silicone tube,revision,mitomycin C,endoscopic DCR

Outcome Measures

Primary Outcomes (1)

  • The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.

    5 years

Secondary Outcomes (1)

  • The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.

    5 years

Study Arms (2)

with tubes or mitomycin

ACTIVE COMPARATOR

After DCR bicanalicular tubes were inserted After re-DCR mitomycin in cottonpads were placed into rhinostoma for 5 minutes

Procedure: DCR with no tubes or mitomycin

without tubes or mitomycin

ACTIVE COMPARATOR

After DCR no tubes were inserted After re-DCR no mitomycin was used

Procedure: DCR with no tubes or mitomycin

Interventions

DCR with no tubes or mitomycinPROCEDURE

The patients were randomized into the two study groups, either with or without the insertion of a bicanalicular silicone tube after primary DCR. In revision group patients were randomized into the two groups,ether with or without application of mitomycin "C" after DCR

Also known as: DCR with tubes or mitomycin
with tubes or mitomycinwithout tubes or mitomycin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (age \> 18), ASAI-III, and were scheduled for primary or revision lacrimal pathway surgery due to recurrent or chronic watering eyes or conjunctival discharge.
  • Patients were excluded if they had previous nasolacrimal surgery, malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.

You may not qualify if:

  • Malignancy in the paranasal sinuses, nasal cavity, or lacrimal pathway, presaccal obstruction, pregnancy or lactation, or mental disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, Northern Savonia, 70210, Finland

Location

Related Publications (1)

  • Penttila E, Hyttinen JM, Hytti M, Kauppinen A, Smirnov G, Tuomilehto H, Seppa J, Nuutinen J, Kaarniranta K. Upregulation of inflammatory genes in the nasal mucosa of patients undergoing endonasal dacryocystorhinostomy. Clin Ophthalmol. 2014 Apr 25;8:799-805. doi: 10.2147/OPTH.S50195. eCollection 2014.

    PMID: 24851037BACKGROUND

MeSH Terms

Conditions

Lacrimal Duct Obstruction

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MitomycinsIndolequinonesQuinonesOrganic ChemicalsAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Juha Seppä, MD,PhD

    Kuopio University Hospital, Otorhinolaryngology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: DCR with/ without tubes Revision DCR with/ without mitomycin
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 10, 2007

First Posted

December 11, 2007

Study Start

September 1, 2004

Primary Completion

December 1, 2011

Study Completion

December 1, 2021

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

FI(1)