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RecruitingNCT06530264

Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

Evaluation of Different Methods of Posterior Flaps Management in External Dacryocystorhinostomy

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
100 (estimated)
Sponsor
Minia University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERDCR6\. 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.

Timeline

Start date
2022-10-15
Primary completion
2024-10-10
Completion
2024-10-15
First posted
2024-07-31
Last updated
2024-07-31

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06530264. Inclusion in this directory is not an endorsement.