Endoscopic DCR With and Without Internal Nasal Splint

May 17, 2026 updated by: Ahmed Magdi Noaman Othman Orabi, Kafrelsheikh University

Endonasal Endoscopic Dacryocystorhinostomy With and Without Internal Nasal Splint-A Comparative Study

This study aims to compare the outcomes of endoscopic DCR performed with versus without internal nasal splints, by assessing functional outcomes, complication rates, and overall success rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafrelsheikh, Egypt
        • Kafrelsheikh University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >18 years. Symptomatic NLDO (epiphora, recurrent dacryocystitis). Fit for general anesthesia

Exclusion Criteria:

  • Congenital dacryocystitis. Canalicular or punctal obstruction. Previous lacrimal surgery. Post-traumatic or post-radiation epiphora. Coexisting nasal pathology (tumors, granulomatous disease, atrophic rhinitis). Immunocompromised or uncontrolled systemic disease. Patients unwilling to undergo endoscopic surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endoscopic DCR with internal nasal splint
Patients will undergo Endoscopic DCR with putting internal nasal splint between middle turbinate and middle meatus
Procedure: Endoscopic DCR with putting internal nasal splint
Patients will undergo Endoscopic DCR with putting internal nasal splint between middle turbinate and middle meatus
Active Comparator: Endoscopic DCR without internal nasal splint.
Patients will undergo Endoscopic DCR without putting internal nasal splint between middle turbinate and middle meatus
Procedure: Endoscopic DCR without putting internal nasal splint
Patients will undergo Endoscopic DCR without putting internal nasal splint between middle turbinate and middle meatus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rates as Stomal patency , absence of formation of synechia and cessation of epiphora.
Time Frame: Evaluation will be done by nasal endoscopic examination of the middle meatus after 1 month
Evaluation will be done by nasal endoscopic examination of the middle meatus after 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

June 5, 2025

Study Completion (Actual)

July 3, 2025

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • KFSIRB200-799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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