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.: PACTR201705002281193 Date of Approval: 10/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Computer assisted comparison between Millard¿s and Fisher¿s Techniques for Complete Unilateral Cleft Lip repair. A Randomized Clinical Trial.
Official scientific title Computer assisted comparison between Millard¿s and Fisher¿s Techniques for Complete Unilateral Cleft Lip repair. A Randomized Clinical Trial.
Brief summary describing the background and objectives of the trial Cleft lip is a very common congenital anomaly; however its surgical repair is one of the most challenging procedures experienced by surgeons. Recreating normal lip architecture with the highest esthetical and symmetrical level to the normal side is the main goal in Unilateral Cleft Lip Surgery. Over the decades, in pursuit of aesthetic primary correction of unilateral cleft lip, various techniques have been proposed [1-4]. Millard¿s rotation advancement flap is one of the most widely used techniques. Fisher¿s anatomical subunit approximation technique is an increasingly used technique. Many methods were described for the assessment of the repaired cleft [4-7]. Objective analysis is commonly performed using an anthropometric method. Aesthetic evaluation of the repaired cleft lip has been done by considering landmarks related to the nose, the body of the lip and the vermilion. Anthropometry and clinical examination were considered best to evaluate the morphology of the repaired cleft lip and nose. With advancement in technology and science, digital imaging and computers now has a great role in any scientific evaluation, also in repaired cleft lip evaluation. Coghlan et al [8-9], described various studies on computer-based analysis to assess the facial symmetry of treated cleft lip and palate patients. The validity of these tools has been confirmed. The aim of the trial is Evaluation and Comparison of the aesthetic outcome between Millard¿s and Fisher¿s techniques for Unilateral Complete Cleft Lip repair clinically by 2 blindly nominated experienced plastic surgery consultants and through objective anthropometric evaluation by using ImageJ software as a quantitative assessment tool.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Complete Unilateral Cleft Lip,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 12/05/2017
Actual trial start date 12/05/2017
Anticipated date of last follow up 12/10/2018
Actual Last follow-up date 12/10/2018
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants) 46
Recruitment status Recruiting
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 Adaptive biased-coin randomization Sequentially numbered, opaque, sealed envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Millard's One Surgery 30 mins Millard¿s rotation advancement flap 23 Active-Treatment of Control Group
Experimental Group Fisher's One Surgery 30 mins Fisher¿s anatomical subunit approximation technique 23
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Any Child with Unilateral Complete Cleft Lip. ¿ Child¿s age shall be 3-6 months old. ¿ Written consent of child¿s parents, free and informed. ¿ Incomplete Unilateral Cleft Lips or any Bilateral Cleft Lips. ¿ Syndromatic Patients. ¿ Patients with comorbidity disease. 3 Month(s) 6 Month(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 18/04/2017 Committee of Ethics and Post-graduate studies-Assiut Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Assiut University Assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Evaluation and Comparison of the aesthetic outcome between Millard¿s and Fisher¿s techniques for Unilateral Complete Cleft Lip repair. 6 months post-operative
Secondary Outcome Clinical assessment by 2 blindly nominated experienced plastic surgery consultants by pre and post-operative photography and recording their remarks according to the following grading criteria: White roll match, Vermilion match, Scar appearance, Cupid bow, Lip Length, Nostril symmetry, Alar dome, Alar base 6 months post-operative
Secondary Outcome Computer assisted objective evaluation including comparison between Cleft Lip Component Symmetry Indices obtained from pictures introduced to ImageJ software as a quantitative assessment tool, to objectively compare the aesthetic outcome between Millard¿s and Fisher¿s techniques and record measurements in each case. 6 months post-operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Plastic and Reconstructive Surgery Assiut University Hospital Assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Plastic & Reconstructive Surgery Assiut University Hospital Assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Plastic & Reconstructive Surgery Assiut University Hospital Assiut 71111 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Department of Plastic & Reconstructive Surgery Assiut University Hospital Assiut 71111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Youssef Hassan plasticclinic66@gmail.com +201001166118 Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Head of Plastic and Reconstructive Surgery Dept.
Role Name Email Phone Street address
Public Enquiries Mostafa Nasser mostafa.nasser88@gmail.com +201000292442 Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Resident of Plastic & Reconstructive Surgery
Role Name Email Phone Street address
Scientific Enquiries Ahmed Kamal ahmedkamal@aun.edu.eg +201060118001 Assiut University Hospital
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Assistant Professor of Plastic & Reconstructive Surgery
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information