Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002809215 Date of Approval: 28/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ologen implants in Dacryocystorhinostomy Surgeries
Official scientific title Application of Biodegradable collagen implants in Dacryocystorhinostomy Surgeries
Brief summary describing the background and objectives of the trial Dacryocystorhinostomy (DCR) is a procedure that creates an epithelium-lined tract between lacrimal sac and nasal mucosa bypassing the occluded nasolacrimal duct. The classic procedure has passed through many minor modifications; however, the basic technique still has a high success rate. This study was conducted to introduce and evaluate the application of Ologen implants in external Dacryocystorhinostomy (DCR) Surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Ear, Nose and Throat,Epiphora,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/12/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 24/12/2018
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simlpe randomisation using a randomisation table Sealed opaque envelope Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Dacrocystorhinostomy with silicone tube Dacrocystorhinostomy with silicone tube 30 Active-Treatment of Control Group
Experimental Group Dacrocystorhinostomy with silicone tube and Ologen implant Dacrocystorhinostomy with silicone tube and Ologen implant 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- primary acquired naso lacrimal duct obstruction (NLDO) 2- +ve regurge test 3- +ve delayed dye clearance test more that 10 minutes in all cases 1 secondary causes for NLDO 2- -ve regurge test 3- history of previous surgery 44 Year(s) 56 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 03/12/2017 Ethics committe menofia Univesity
Ethics Committee Address
Street address City Postal code Country
Yasin abd el ghaffar st. Shibin el koom 72427 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Symptomatic epiphora 1- 1 week 2- 1 month 3- 3 months 4- 6 months
Secondary Outcome Discharge 1- 1 week 2- 1 month 3- 3months 4- 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menofia University Hospitals Yasin bd el ghaffar st. Shibin el koom 72427 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menofia University Yasin abd elghaffer st. Shibin el koom 72427 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menofia University Yasin abd el ghaffar st. Shibin el koom 72427 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ophthalmologt department, Menofia University yYasin abd el ghaffar st. Shibin el koom 72427 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hatem Marey hatemmarey@yahoo.com 00201063252918 Zaki shabana st.
City Postal code Country Position/Affiliation
Shibin el koom 72427 Egypt Assisstant professor of ophthalmology
Role Name Email Phone Street address
Public Enquiries Sameh El Gohary sameh_elgouhary@yahoo.com 00201063253917 Ali St.
City Postal code Country Position/Affiliation
Shibin el koom 72427 Egypt physicion
Role Name Email Phone Street address
Scientific Enquiries Sameh mandour dr_ssmandou@hotmail.com 00201063254717 mohamed st.
City Postal code Country Position/Affiliation
Shibin elkoom 72427 Egypt assisstant professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information