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Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

Evaluation of Different Methods of Posterior Flaps Management in External Dacryocystorhinostomy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06530264
Enrollment
100
Registered
2024-07-31
Start date
2022-10-15
Completion date
2024-10-15
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Nasolacrimal Duct Obstruction

Keywords

Posterior flap, DCR, NLDO

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.

Interventions

OTHERDCR

6\. An H shaped incision at the postero-inferior lacrimal sac is made, with a long anterior flap and shorter posterior flap. Similarly an H shaped incision at the nasal mucosa is made. The posterior flap of lacrimal sac is sutured with posterior flap of nasal mucosa in interrupted fashion using 6-0 vicryl sutures in Group A, while in Group B the posterior flap is trimmed without suturing.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Masking description

1. Patients with chronic dacryocystits, 2. primary nasolacrimal duct obstruction 3. Lacrimal mucocele 4. Lacrimal fistula

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Patients with chronic dacryocystits, * primary nasolacrimal duct obstruction * Lacrimal mucocele * Lacrimal fistula

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Management of posterior flap in external DCRpatient evaluated at 2 months after surgery then at 4th month then 6th monthEvaluation of different methods of posterior flaps management in external dacryocystorhinostomy using nasal endoscopy for evaluation of outcomes

Countries

Egypt

Contacts

Primary ContactMohammed Sayed Abdelmaaboud, MD
oph.msa1990@gmail.com01092503977
Backup ContactMohamed Farouk Sayed, Prof
mohamed.osman@mu.edu.eg01062555738

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026