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

NCT06166238 | Unknown

• 1 other identifier: Unilater cleft lip.
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cleft Lip, Unilateral

Outcome Measures

Primary Outcomes (1)

• functional and aesthetic outcomes after repair

  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.

  6 months

Study Arms (2)

Group I

Patients who will be subjected to Millard Technique

Procedure: Millard and Tension Randal Technique

Group II

patients who will be subjected to Tension Randal

Procedure: Millard and Tension Randal Technique

Interventions

Millard and Tension Randal Technique 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 I; Group II

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with complete and incomplete unilateral cleft lip.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

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

  PMID: 3491113 BACKGROUND

• 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.

  PMID: 19697433 RESULT

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

  PMID: 8275626 RESULT

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sherif Saleh, officer

CONTACT

+201068224; sherifabdelnasser.20@hotmail.com

Mohamed ElShazly, Prof.Dr

CONTACT

+201006667095; elshazly@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Plastic & Reconstructive surgery at Assiut university

Study Record Dates

• First Submitted: December 3, 2023
• First Posted: December 12, 2023
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12