Faculty of medicine ,Minia university
Minya, 61519, Egypt
Location status: Recruiting
Location contact
Mohamed Farouk Sayed, Prof
CONTACT
01062555738 ext. +20
Mohammed Sayed Abdelmaaboud, MD
CONTACT
01092503977 ext. +20
Recruiting
NCT Number: NCT06530264
Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
dCR
Other- 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.
Other names: posterior flap management
Primary outcomes
-
Management of posterior flap in external DCR
Time frame: 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
Study contacts
Contact information is provided by the study sponsor or research team.
Mohamed Farouk Sayed, Prof
CONTACT
01062555738 ext. +20
Mohammed Sayed Abdelmaaboud, MD
CONTACT
01092503977 ext. +20
Sponsors and collaborators
Lead sponsor
Minia University
Other
Registry information
Official study title
Evaluation of Different Methods of Posterior Flaps Management in External Dacryocystorhinostomy
Important dates
- Study start
- 2022
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Jul 31, 2024
- Registry last updated
- Jul 31, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.