Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.

Not yet recruiting

• Conditions: Cleft Lip, Unilateral
• Interventions: Procedure: Millard and Tension Randal Technique

• Registration Number: NCT06166238
• Lead Sponsor: Assiut University

Brief Summary

"the investigators will compare the quantitative and qualitative (functional and aesthetic outcomes) of these two surgical approaches for repair of the unilateral cleft lip using an evaluation protocol developed many years ago by the research council of Operation Smile, a non- profit organization based in Virginia Beach, USA. Operation Smile delivers charity management of cleft lip and palate cases in many different developing countries around the world. Under this protocol, a dual rating system has been developed with two scores: one preoperative score concerning the severity of cleft and one score for the postoperative results.

Detailed Description

One of the common congenital malformations in the head and neck is cleft lips. The prevalence of cleft lip is about 1:1000 of live birth; it also more common in boys and tends to present on the left side with a 6:3:1 ratio of left to right to bilateral. Many facial malformations, including cleft lip, are linked with environmental, maternal, and genetic factors, such as exposure to teratogen drugs, including isotretinoin, alcohol, or anticonvulsants. Similarly, some habits or diseases during pregnancy increase the risk of the cleft lip as smoking, pregestational and gestational diabetes, and specific nutritional deficiencies. The treatment begins soon after the child's birth and continues until adulthood. The purpose of cleft treatment is aesthetic and functional rehabilitation. Surgical repair is important for facial growth preservation, normal speech formation and development of proper dentition. The less number of interventions, the less the scaring results and hence, growth retardation Nowadays, the most commonly used techniques in managing unilateral cleft lip (UCL) are Millard's rotation advancement and Tennison Randall's triangular flap repairs. This study aimed to use anthropometric analysis by anthropometric measurements taken pre and post operation to evaluate the quantitative assessment of the modified Millard technique compared with the Tennison Randall technique in UCL repair.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-03
• Study First Posted: 2023-12-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-26
• Study Start: 2024-12-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients are generally fit
• Patients with unilateral with or without cleft palate
• Patients with compliance for follow up.

Exclusion Criteria

• Syndromic cases.
• Patients are generally unfit.
• Secondary cleft lip.
• Age less than 3 months, more than 4 years
• Bilateral cleft lip.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group II	Millard and Tension Randal Technique	patients who will be subjected to Tension Randal
Group I	Millard and Tension Randal Technique	Patients who will be subjected to Millard Technique

Primary Outcome Measures

Name	Time	Method
functional and aesthetic outcomes after repair	6 months	two scores: one preoperative score concerning the severity of cleft and one score for the Assessment of the results based on the post-operative scoring sheet included items for evaluating the integrity and symmetry of the Cupid's bow, nasal symmetry, lateral lip symmetry, vermilion contour, and white roll continuity. The individual scores for each factor were combined to yield an overall rating of poor, fair, good, and excellent.