Evaluation of Different Methods of Posterior Flap Managem... | NCT06530264

Studies
Evaluation of Different Methods of Posterior Flap Management in External Dacryocystorhinostomy

NCT06530264

Sponsor

Minia University

Status

Recruiting

Last Update Posted

Jul 31, 2024Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Acquired Nasolacrimal Duct Obstruction

Interventions

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2022Actual

Primary Completion Date

Oct 10, 2024Estimated

Completion Date

Oct 15, 2024Estimated

First Submitted Date

Jul 19, 2024

First Submission Date that Met QC Criteria

Jul 26, 2024

First Posted Date

Jul 31, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2024

Last Update Posted Date

Jul 31, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohammed Sayed Abdelmaaboud Abdelmoneem, Mohammed Sayed Abdelmaaboud, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
External DCR	Other	Different techniques in posterior flap management	Other: DCR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed Sayed Abdelmaaboud, MD	Contact	01092503977	+20	oph.msa1990@gmail.com
Mohamed Farouk Sayed, Prof	Contact	01062555738	+20	mohamed.osman@mu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine ,Minia university	Recruiting	Minya		61519	Egypt

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.

Masking Info

Masking

None (Open Label)

Masking Description

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

Who Masked

Not provided