Endoscopic Dacryocystorhinostomy Prospective Research

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Juha Seppa, Kuopio University Hospital

ClinicalTrials.gov Identifier:

NCT00571129

First received: December 10, 2007

Last updated: March 10, 2016

Last verified: March 2016

History of Changes

Purpose

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.

Condition	Intervention
Lacrimal Duct Obstruction	Procedure: DCR


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Recovery After Endoscopic Dacryocystorhinostomy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The EN-DCR operation influence on the patients subjective symptoms and QoL before and after operation. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	80
Study Start Date:	September 2004
Estimated Study Completion Date:	December 2016
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
surgical	Procedure: DCR 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

Eligibility


Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00571129

Locations


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

Sponsors and Collaborators

Kuopio University Hospital

Investigators


Study Chair:	Juha Seppä, MD,PhD	Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland

More Information

Publications:

Penttilä E, Hyttinen JM, Hytti M, Kauppinen A, Smirnov G, Tuomilehto H, Seppä 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.


Responsible Party:	Juha Seppa, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00571129 History of Changes
Other Study ID Numbers:	KUH5551812 255104
Study First Received:	December 10, 2007
Last Updated:	March 10, 2016
Health Authority:	Finland: Ethics Committee

Keywords provided by Kuopio University Hospital:


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

Additional relevant MeSH terms:


Lacrimal Duct Obstruction Lacrimal Apparatus Diseases Eye Diseases

ClinicalTrials.gov processed this record on September 23, 2016

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