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

NCT ID: NCT06166238

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-01

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.

Conditions

Cleft Lip, Unilateral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I

Patients who will be subjected to Millard Technique

Millard and Tension Randal Technique

Intervention Type: PROCEDURE

Millard recognized that the majority of Cupid's bow, one philtral column, and the philtral dimple were intact on the medial aspect of a unilateral cleft lip but required rotation to shift the tissue into a normal anatomic position (Millard, 1964b) The Tennison-Randall technique involves a back-cut that extends from the cleft Cupid's bow peak toward the center of the philtrum that is filled by a laterally based triangular flap whose width is the measured deficiency in lip height.

Group II

patients who will be subjected to Tension Randal

Millard and Tension Randal Technique

Intervention Type: PROCEDURE

Millard recognized that the majority of Cupid's bow, one philtral column, and the philtral dimple were intact on the medial aspect of a unilateral cleft lip but required rotation to shift the tissue into a normal anatomic position (Millard, 1964b) The Tennison-Randall technique involves a back-cut that extends from the cleft Cupid's bow peak toward the center of the philtrum that is filled by a laterally based triangular flap whose width is the measured deficiency in lip height.

Interventions

Millard and Tension Randal Technique

Millard recognized that the majority of Cupid's bow, one philtral column, and the philtral dimple were intact on the medial aspect of a unilateral cleft lip but required rotation to shift the tissue into a normal anatomic position (Millard, 1964b) The Tennison-Randall technique involves a back-cut that extends from the cleft Cupid's bow peak toward the center of the philtrum that is filled by a laterally based triangular flap whose width is the measured deficiency in lip height.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sherif Abdelnaser Ibrahim

Resident doctor at Plastic & Reconstructive surgery at Assiut university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sherif Saleh, officer

Role: CONTACT

Phone: +201068224

Email: sherifabdelnasser.20@hotmail.com

Mohamed ElShazly, Prof.Dr

Role: CONTACT

Phone: +201006667095

Email: elshazly@aun.edu.eg

References

Willhite CC, Hill RM, Irving DW. Isotretinoin-induced craniofacial malformations in humans and hamsters. J Craniofac Genet Dev Biol Suppl. 1986;2:193-209.

Reference Type: BACKGROUND

PMID: 3491113 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19697433 (View on PubMed)

Jones MC. Facial clefting. Etiology and developmental pathogenesis. Clin Plast Surg. 1993 Oct;20(4):599-606.

Reference Type: RESULT

PMID: 8275626 (View on PubMed)

Other Identifiers

Unilater cleft lip.

Identifier Type: -

Identifier Source: org_study_id