Endoscopic Dacryocystorhinostomy Prospective Research

Overview

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.

Full Title of Study: “Recovery After Endoscopic Dacryocystorhinostomy”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: December 2011

Interventions

• 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

Arms, Groups and Cohorts

• 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
• Active Comparator: without tubes or mitomycin
  • After DCR no tubes were inserted After re-DCR no mitomycin was used

Clinical Trial Outcome Measures

Primary 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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Kuopio University Hospital
• Provider of Information About this Clinical Study
  • Principal Investigator: Juha Seppa, PhD – Kuopio University Hospital
• Overall Official(s)
  • Juha Seppä, MD,PhD, Study Chair, Kuopio University Hospital, Otorhinolaryngology

References

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.