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.: PACTR202004788564686 Date of Approval: 16/04/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Surgical Excision of Internal Angular Dermoid.
Official scientific title Aesthetic Outcome of Three Surgical Techniques for Excision of Internal Angular Dermoid, A Randomized Clinical Trial.
Brief summary describing the background and objectives of the trial Dermoid cysts are the most common periorbital mass in infants and children [1]. They arise from abnormal implantation of surface ectoderm during suture line closure [2]. Surgical excision is usually recommended even in absence of symptoms because long-standing dermoid cysts tend to leak with subsequent inflammation [2]. Various surgical approaches for the excision have been reported. The surgeon’s goal is to remove the dermoid with intact cyst wall through an incision that allows good exposure, while the main parent’s concern is to avoid a visible scar [3-5]. Internal angular dermoids are less frequent than external ones, but more difficult to remove without visible scar. In an effort to minimize visible scar, some authors used medial lid crease incision while others used percutaneous aspiration before complete excision of the wall through very small incision. In this study, we aim to compare the cosmetic results of 3 different approaches for the excision of the infrequently reported internal angular dermoids; the classic subbrow [5], medial upper lid crease [3,4], and direct percutaneous aspiration before excision through minimum incision [6].
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2020
Actual trial start date
Anticipated date of last follow up 01/04/2021
Actual Last follow-up date 01/04/2021
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
R 114 Fayoum University Faculty of Medicine
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Subbrow incision 6 months Excision of internal angular dermoid through medial sub-brow incision 15 Active-Treatment of Control Group
Control Group Medial upper lid crease incision 6 months Excision of internal angular dermoid through medial upper lid crease incision 15 Active-Treatment of Control Group
Experimental Group Percutaneous aspiration before excision 6 months percutaneous aspiration of internal angular dermoid before excision through minimum incision 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with internal angular dermoid cyst. Recurrent cases Patients older than 18 years old Adolescent: 13 Year-18 Year,Preschool Child: 2 Year-5 Year 1 Year(s) 20 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
Yes 12/04/2020 Fayoum University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Kiman Fares district Fayoum 63514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Scar evaluation 1 months, 3 months
Secondary Outcome Complete exision intraoperative
Secondary Outcome Pathological reports 1 week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospitals Kiman Fares District Fayoum Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Mohammed Mohammed Diab 11 George Nirose St, Al Mesalla Square Fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Fayoum University Hospita Kiman Fares district Fayoum Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Kareem Bakr Elessawy 3 Toman Bay ST, Ibn Sandr Square, Msr Elgdida Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +2001016737314 11 George Nirose from El Nabawy St , Al mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Lecturer of Ophthalmology Fayoum University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201016737314 11 Gorge Nirose St, From Elnabawy st, Al Mesalla
City Postal code Country Position/Affiliation
Fayoum Egypt Lecture of Ophthalmology Fayoum University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Kareem Elessawy kemos1984@yahoo.com +201144008882 3 Toman bay St,Inb Sandr square, Msr ELgdida
City Postal code Country Position/Affiliation
Fayoum Egypt Lecturer of Ophthalmology Cairo university Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Preoperative data (age, gender, laterality, orbital CT scans, pathology report) Statistical Analysis Plan,Study Protocol 1 years controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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