Clinical trial NCT06166238: Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.
Official title: Comparative Study Between Millard and Tennison Randall Techniques in Complete and Incomplete Cleft Lip Repair.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cleft Lip, Unilateral
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complete and incomplete unilateral cleft lip.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: functional and aesthetic outcomes after repair
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Willhite CC, Hill RM, Irving DW. Isotretinoin-induced craniofacial malformations in humans and hamsters. J Craniofac Genet Dev Biol Suppl. 1986;2:193-209.
citation: Parker SE, Mai CT, Strickland MJ, Olney RS, Rickard R, Marengo L, Wang Y, Hashmi SS, Meyer RE; National Birth Defects Prevention Network. Multistate study of the epidemiology of clubfoot. Birth Defects Res A Clin Mol Teratol. 2009 Nov;85(11):897-904. doi: 10.1002/bdra.20625.
citation: Jones MC. Facial clefting. Etiology and developmental pathogenesis. Clin Plast Surg. 1993 Oct;20(4):599-606.