Endoscopic Dacryocystorhinostomy Prospective Research

Kuopio University Hospital

Status: Unknown

Conditions: Lacrimal Duct Obstruction

Treatments: Procedure: DCR with no tubes or mitomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00571129

255104 (Other Identifier)

KUH5551812

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

with tubes or mitomycin

Active Comparator group

Description:

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

Treatment:

Procedure: DCR with no tubes or mitomycin

without tubes or mitomycin

Active Comparator group

Description:

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

Treatment:

Procedure: DCR with no tubes or mitomycin