UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058008 |
|---|---|
| Receipt number | R000066307 |
| Scientific Title | External dacryocystorhinostomy with and without silicone intubation |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/05/29 10:37:15 |
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Basic information
Public title
External dacryocystorhinostomy
Acronym
ED
Scientific Title
External dacryocystorhinostomy with and without silicone intubation
Scientific Title:Acronym
EDWXSI
Region
| Africa |
Condition
Condition
Ophthalmology: nasolacrimal duct obstruction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to evaluate and compare the surgical outcomes of external dacryocystorhinostomy (DCR) performed with and without silicone intubation in patients diagnosed with chronic nasolacrimal duct obstruction. By conducting a prospective randomized trial over six years at a tertiary ophthalmology center in Mali, the study aimed to determine whether the use of silicone intubation improves surgical success rates, reduces revision surgeries, and minimizes postoperative complications such as stenosis or granuloma formation. The findings intend to contribute to optimizing surgical protocols for managing nasolacrimal duct obstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Surgical Success Rate:
- Defined by resolution of epiphora and anatomical patency confirmed by syringe irrigation.
- Compared between DCR with and without silicone intubation.
Revision Surgery Rate
- Proportion of patients requiring repeat DCR.
- Used to assess the durability of surgical outcomes.
Incidence of Postoperative Complications
- Including stenosis, granuloma formation, and mucous discharge.
- Evaluates the safety profile of each surgical approach.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
With Silicone Intubation
Interventions/Control_2
Without silicone intubation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 13 | years-old | <= |
Age-upper limit
| 78 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 13 to 78 years
Confirmed diagnosis of chronic nasolacrimal duct obstruction (NLDO)
Symptoms persisting despite conservative medical treatment
Ability and willingness to provide written informed consent
Eligibility for external dacryocystorhinostomy (DCR) surgery under local or general anesthesia.
Key exclusion criteria
History of trauma-related nasolacrimal duct obstruction
Nasolacrimal obstruction due to tumors or malignancies
Previous lacrimal or nasal surgery
Contraindications to undergoing DCR under local or general anesthesia
Inability or unwillingness to provide informed consent.
Target sample size
107
Research contact person
Name of lead principal investigator
| 1st name | Nouhoum |
| Middle name | |
| Last name | Guirou |
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Division name
Ophthalmology/Oculoplastics
Zip code
91093
Address
Boulevard du Peuple Centre commercial Bamako/Mali
TEL
+22366809004
guiroun@gmail.com
Public contact
Name of contact person
| 1st name | Nouhoum |
| Middle name | |
| Last name | Guirou |
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Division name
Ophthalmology/Oculoplastics
Zip code
91093
Address
Boulevard du peuple
TEL
+22366809004
Homepage URL
guiroun@gmail.com
Sponsor or person
Institute
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Institute
Department
Personal name
Funding Source
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Centre Hospitalier Universitaire / Institut d'ophtalmologie Tropicale d'Afrique (CHU-IOTA)
Address
Boulevard du Peuple Centre commercial Bamako/Mali
Tel
+22366809004
guiroun@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 29 | Day |
Related information
URL releasing protocol
guiroun@gmail.com
Publication of results
Unpublished
Result
URL related to results and publications
guiroun@gmail.com
Number of participants that the trial has enrolled
107
Results
This study shows that external DCR, with or without silicone intubation, produces excellent results. Silicone intubation, however, is associated with better outcomes, such as fewer revisions and less stenosis. Nonetheless, larger samples and longer follow-up periods are needed to provide clear guidance on using silicone intubation for external DCR.
Results date posted
| 2025 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (range: 13 to 78 years
Gender 47.17% men and 52.83% women in silicone group, and 51.85% men and 48.15% women in non silicone group.
Participant flow
Silicone group: 53 started and completed
Without silicone group: 54 started and completed
Adverse events
None
Outcome measures
Age
Sex
Cause of NLDO
Symptom Duration
Anesthesia
Excessive Bleeding
Surgery Duration
Revision
Tube
Follow-up Duration
Post-operative Complications
Success Rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 29 | Day |
Last modified on
| 2025 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066307
