Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

Not Applicable

Recruiting

• Conditions: Acquired Nasolacrimal Duct Obstruction
• Interventions: Other: DCR

• Registration Number: NCT06530264
• Lead Sponsor: Minia University

Brief Summary

The aim of DCR is to form a new, mucosa-lined pathway between the lacrimal sac and the nasal cavity where tears can bypass a lacrimal obstruction and drain directly in the nose. The original external approach was described in 19046. In 1920s, mucosal flap anastomosis was added to the procedure as a modification7, and since then, many new modifications have been made to improve the original procedure.

Detailed Description

Aim of The Study

• To compare intraoperative details and postoperative endonasal endoscopic findings and their effects on success rate of external dacryocystorhinostomy with and without anastomosis of posterior mucosal flaps.

Patients and Methods

Study Design: This will be a prospective interventional comparative clinical study. It will include two groups according to the surgical procedure:- Group A: includes 30 eyes that will be treated with external DCR with anastomosis of posterior mucosal flaps .

Group B: includes 30 eyes that will be treated with external DCR with amputation of posterior mucosal flaps .

Study Population:

Study participants will be: 60 eyes undergo external DCR . All patients included in this study will be verbally briefed about the details and the nature of the study \& will sign a written consent according to the local Ethics Committee of Minia University Faculty of Medicine. The study will be conducted in Ophthalmology department, Minia university Hospital, Egypt.

Study Timeline

• Study Start: 2022-10-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-10-10
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

• Recurrent cases.
• Age under 5 years.
• Associated nasal pathology.
• Sever dry eye
• Patients unfit for general anaesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
External DCR	DCR	Different techniques in posterior flap management

Primary Outcome Measures

Name	Time	Method
Management of posterior flap in external DCR	patient evaluated at 2 months after surgery then at 4th month then 6th month	Evaluation of different methods of posterior flaps management in external dacryocystorhinostomy using nasal endoscopy for evaluation of outcomes

Trial Locations

Locations (1)

Faculty of medicine ,Minia university; 🇪🇬 Minya, Egypt