Endoscopic Dacryocystorhinostomy Prospective Research

February 21, 2020 updated by: Juha Seppa, Kuopio University Hospital

Recovery After Endoscopic Dacryocystorhinostomy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • North-Savo
      • Kuopio, North-Savo, Finland, 70210
        • Kuopio University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: with tubes or mitomycin
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

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

Other Names:
  • DCR with tubes or mitomycin
ACTIVE_COMPARATOR: without tubes or mitomycin
After DCR no tubes were inserted After re-DCR no mitomycin was used
Procedure: DCR with no tubes or mitomycin

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

Other Names:
  • DCR with tubes or mitomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The success rate after primary DCR with and without silicone tubes. The success rate after revisio DCR with and without Mitomycin C.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kuopio University Hospital

Investigators

  • Study Chair: Juha Seppä, MD,PhD, Kuopio University Hospital, Otorhinolaryngology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2004

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 10, 2007

First Posted (ESTIMATE)

December 11, 2007

Study Record Updates

Last Update Posted (ACTUAL)

February 25, 2020

Last Update Submitted That Met QC Criteria

February 21, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUH5551812
  • 255104 (OTHER: Kuopio University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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