Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

NCT06530264 | Recruiting DMC

• 1 other identifier: Posterior flap managing in DCR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Nasolacrimal Duct Obstruction

Keywords

Posterior flap; DCR; NLDO

Outcome Measures

Primary Outcomes (1)

• Management of posterior flap in external DCR

  Evaluation of different methods of posterior flaps management in external dacryocystorhinostomy using nasal endoscopy for evaluation of outcomes

  patient evaluated at 2 months after surgery then at 4th month then 6th month

Study Arms (1)

External DCR

OTHER

Different techniques in posterior flap management

Other: DCR

Interventions

DCR 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.

Also known as: posterior flap management

External DCR

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of medicine ,Minia university

Minya, 61519, Egypt

RECRUITING

Central Study Contacts

Mohammed Sayed Abdelmaaboud, MD

CONTACT

01092503977; oph.msa1990@gmail.com

Mohamed Farouk Sayed, Prof

CONTACT

01062555738; mohamed.osman@mu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 1. Patients with chronic dacryocystits, 2. primary nasolacrimal duct obstruction 3. Lacrimal mucocele 4. Lacrimal fistula
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohammed Sayed Abdelmaaboud

Model Details: 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 Record Dates

• First Submitted: July 19, 2024
• First Posted: July 31, 2024
• Study Start: October 15, 2022
• Primary Completion: October 10, 2024
• Study Completion: October 15, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

EG (1)