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Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

NCT ID: NCT06530264

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-15

Study Completion Date

2024-10-15

Brief Summary

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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

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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

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Acquired Nasolacrimal Duct Obstruction

Keywords

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Posterior flap DCR NLDO

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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External DCR

Different techniques in posterior flap management

Group Type OTHER

DCR

Intervention Type OTHER

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.

Interventions

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DCR

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.

Intervention Type OTHER

Other Intervention Names

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posterior flap management

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Sayed Abdelmaaboud Abdelmoneem

Mohammed Sayed Abdelmaaboud

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine ,Minia university

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed Sayed Abdelmaaboud, MD

Role: CONTACT

Phone: 01092503977

Email: [email protected]

Mohamed Farouk Sayed, Prof

Role: CONTACT

Phone: 01062555738

Email: [email protected]

Facility Contacts

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Mohammed Sayed Abdelmaaboud, MD

Role: primary

Mohamed Farouk Sayed, Prof

Role: backup

Other Identifiers

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Posterior flap managing in DCR

Identifier Type: -

Identifier Source: org_study_id