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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202511565322554 Date of Registration: 07/11/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Optimizing Outcomes of Woo Palatoplasty versus Pushback Palatoplasty in Surgical Surgical treatment of Primary Cleft Palate
Official scientific title Optimizing Outcomes of Woo Palatoplasty versus Pushback Palatoplasty in Surgical Surgical treatment of Primary Cleft Palate
Brief summary describing the background and objectives of the trial Cleft palate is a common congenital craniofacial anomaly that requires early surgical intervention to restore both form and function. Optimal palatal repair aims to separate the nasal and oral cavities, enabling normal speech and feeding while minimizing complications such as fistula formation and velopharyngeal insufficiency (VPI). Among the several surgical techniques available, Woo palatoplasty and Bardach two-flap palatoplasty with intervelar veloplasty (IVVP) are widely utilized and have shown promising results in primary cleft palate patients. Woo palatoplasty focuses on repositioning and reconstructing the levator veli palatini muscle to restore the velopharyngeal sphincter mechanism, which is critical for speech quality and preventing nasal air escape during phonation. This method has been associated with improved soft palate length and enhanced velopharyngeal function, contributing to better speech outcomes and reduced hypernasality. Conversely, pushback palatoplasty involves posteriorly repositioning the palatal mucoperiosteal flaps to lengthen the soft palate, typically used for wider cleft palates, and aims to improve function through palatal lengthening and reconstruction. Both techniques aim to improve velopharyngeal competence, but differences exist in surgical complexity, postoperative complication rates, and speech outcomes. Complications such as oronasal fistula and wound dehiscence remain significant challenges influencing the long-term success of palatal repair. Additionally, velopharyngeal insufficiency, characterized by inadequate soft palate closure against the posterior pharyngeal wall, leads to hypernasal speech and secondary articulation disorders, often necessitating further surgical intervention This study seeks to fill the gap in current evidence by comparing Woo palatoplasty and Pushback palatoplasty in primary cleft palate patients. The goal is to optimize surgical protocols by evaluating functional outcomes, compl
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/11/2025
Actual trial start date 01/11/2025
Anticipated date of last follow up 30/11/2026
Actual Last follow-up date 30/11/2026
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet 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 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
Experimental Group Pushback Palatoplasty once once Involves raising oral and nasal mucoperiosteal flaps bilaterally, with posterior repositioning ("pushback") of the palatal tissue to lengthen the soft palate. This technique is typically used for wider cleft palates and aims to improve velopharyngeal function by increasing palatal length. Management of the raw areas created on the nasal surface after flap mobilization may involve additional flap coverage techniques such as buccal myomucosal flaps. 20
Control Group Woo Palatoplasty once once Involves careful dissection and reconstruction of the levator veli palatini muscle sling to restore muscular continuity and velopharyngeal mechanism. Muscle repositioning is performed intravelarly without extensive flap elevation. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients diagnosed with primary cleft palate requiring surgical repair • Age: Infants and children aged 1 months to 5 years (selected to include standard timing for primary repair) • No prior surgical intervention for cleft palate repair • Medically fit to undergo surgery under general anesthesia • Informed consent obtained from parents or guardians • Patients with syndromic clefts or associated complex congenital anomalies • History of previous palatal surgery or secondary palate repair • Patients with severe systemic illness or contraindications for surgery • Incomplete medical records or lost to follow-up Infant: 1 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 1 Month(s) 5 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 15/10/2025 Institutional Review Board of Faculty of Medicine Assiut university
Ethics Committee Address
Street address City Postal code Country
Assiut university Assiut university 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Improvement in velopharyngeal function as assessed by standardized perceptual speech evaluation conducted by experienced speech-language pathologists, complemented by nasopharyngoscopic examination to objectively determine the effectiveness of soft palate closure. 3 month postoperative
Secondary Outcome Incidence of postoperative complications, including oronasal fistula formation, wound dehiscence, and surgical site infection. 3 month postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university Hospital Assiut university Asyut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Abdelhady Akram Mohamed Himony Assiut university Asyut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Abdelhady Akram Mohamed Himony Assiut university Asyut 71515 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Abdelhady Akram Abdulhadi.akram99@gmail.com +201101303189 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt residant doctor at plastic surgery department
Role Name Email Phone Street address
Principal Investigator Mohamed Mahmoud Thabet Elshazly elshazly@aun.edu.eg +201227606041 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt professor of plastic surgery
Role Name Email Phone Street address
Scientific Enquiries Ahmed Mohamed Ali Tohamy ahmedtohamy@aun.edu.eg +201002660832 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt Associate Professor Faculty of Medicine Assiut University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant data (IPD) collected during this study will not be shared with other researchers or organizations because they contain potentially sensitive information and participants did not provide consent for data sharing. However, summary results of the study will be made publicly available within 12 months of study completion, in accordance with WHO requirements Informed Consent Form There is no plan to share individual participant data (IPD) at any time, as the dataset contains sensitive information and participants did not provide consent for data sharing Access to individual participant data will not be granted because the data contain sensitive information and participants did not consent to data sharin
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 01/11/2025 berif background about study This study seeks to fill the gap in current evidence by comparing Woo palatoplasty and Pushback palatoplasty in primary cleft palate patients. The goal is to optimize surgical protocols by evaluating functional outcomes, complication rates, and speech development, ultimately improving quality of life for affected individuals. The aim of this study is to compare and optimize the clinical outcomes of Woo palatoplasty and pushback palatoplasty in the surgical management of primary cleft palate patients, focusing on speech development, velopharyngeal function, and complication rates. Cleft palate is a common congenital craniofacial anomaly that requires early surgical intervention to restore both form and function. Optimal palatal repair aims to separate the nasal and oral cavities, enabling normal speech and feeding while minimizing complications such as fistula formation and velopharyngeal insufficiency (VPI). Among the several surgical techniques available, Woo palatoplasty and Bardach two-flap palatoplasty with intervelar veloplasty (IVVP) are widely utilized and have shown promising results in primary cleft palate patients. Woo palatoplasty focuses on repositioning and reconstructing the levator veli palatini muscle to restore the velopharyngeal sphincter mechanism, which is critical for speech quality and preventing nasal air escape during phonation. This method has been associated with improved soft palate length and enhanced velopharyngeal function, contributing to better speech outcomes and reduced hypernasality. Conversely, pushback palatoplasty involves posteriorly repositioning the palatal mucoperiosteal flaps to lengthen the soft palate, typically used for wider cleft palates, and aims to improve function through palatal lengthening and reconstruction. Both techniques aim to improve velopharyngeal competence, but differences exist in surgical complexity, postoperative complication rates, and speech outcomes. Complications such as oronasal fistula and wound dehiscence remain significant challenges influencing the long-term success of palatal repair. Additionally, velopharyngeal insufficiency, characterized by inadequate soft palate closure against the posterior pharyngeal wall, leads to hypernasal speech and secondary articulation disorders, often necessitating further surgical intervention This study seeks to fill the gap in current evidence by comparing Woo palatoplasty and Pushback palatoplasty in primary cleft palate patients. The goal is to optimize surgical protocols by evaluating functional outcomes, compl