Endoscopic Dacryocystorhinostomy Prospective Research - Full Text View

Sponsor:	Kuopio University Hospital
Information provided by (Responsible Party):	Grigori Smirnov, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00571129

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 2012
Estimated 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
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

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

No publications provided

Responsible Party:	Grigori Smirnov, PhD,MD,ENT spesialist, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00571129 History of Changes
Other Study ID Numbers:	KUH5551812, 255104
Study First Received:	December 10, 2007
Last Updated:	October 27, 2011
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 February 09, 2012