Comparison of Techniques in Repair of Unilateral Cleft Lip

Unilateral Cleft Lip Clinical Trial

Official title:

Unilateral Cleft Lip Repair: Quantitative (Anthropometric) Comparative Assessment of Modified Millard vs Tennison-Randall Techniques.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05080855
• Other study ID #: 150318
• Status: Completed
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: September 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Over the past century, there have been major advances in unilateral cleft-lip repair techniques toward the method's modern form. The first documented cleft-lip repair involved simple freshening and approximation of the cut cleft edges, followed by the use of curved incisions to allow lengthening of the lip. Straight-line closure repairs were used in the early 1900; however, straight-line closures had the disadvantage of creating a vertical scar contracture, leading to notching of the lip. This led to the development of several methods in the mid-twentieth century that are grouped as quadrangular flaps, triangular flaps, and rotation-advancement techniques.

The two basic techniques that are most commonly used for unilateral cleft lip (UCL) closure are the Tennison-Randall and the Millard rotation_advancement techniques. both techniques address the importance of repositioning the lip muscle (orbicularis oris) in the correct anatomic orientation for optimal aesthetic and functional outcomes.

The ultimate goal of cleft lip surgery is to achieve a perfectly symmetrical lip and nose. It has been shown that for the general population, the more symmetrical the face, the more attractive the face is. The appearance and symmetry of the nasolabial region is also seen as one of the most important characteristics when evaluating the results of any facial surgery.

Measurement of treatment outcome is vital to evaluate the success of cleft management and the degree of improvement, especially in the present age of evidence-based medicine where treatment guidelines for best practice are becoming an integral part of contemporary clinical practice.

The good goal of cleft lip repair is a symmetrical and balanced lip with minimal scar restoring the natural contours of the face, as well as correcting functional anatomy.

Objectives To evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison_ Randall technique in unilateral cleft lip (ucl) repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 5, 2020
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 6 Months

Eligibility

Inclusion Criteria:

1. Patient with age from 2 months old to 6 months old.

2. Patient with unilateral cleft lip complete or incomplete type.

Exclusion Criteria:

1. Patient with age less than 2 months old or more than 6 months old.

2. Patients with bilateral cleft lip

3. Patients with recurrent cleft lip.

4. Patients with associated major congenital anomalies like major cardiac anomalies.

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip

Intervention

Procedure:
• modified Millard technique vs Tennison-Randall technique
evaluate the quantitative (anthropometric) assessment of modified Millard technique in comparison to Tennison-Randall technique in unilateral cleft lip (ucl) repair. Inclusion criteria: Patient with ages from 2 months old to 6 months old, Patient with unilateral cleft lip complete or incomplete type.

Locations

Country	Name	City	State
Egypt	Pediatric Surgery department, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Post-operative Complications	Early: Wound infection. Wound dehiscence.; Late: Wound scarring. Lip notch	1 month
Secondary	Anthropometry assessment of Cosmetic Results	Anthropometric measurements were recorded from a two dimensional full-frontal facial photograph of subjects will be taken with a digital camera. The following anthropometric measurements will be taken. Preoperative(measurements will be taken before the surgery).; Vertical lip height on( both cleft and non-cleft side), Horizontal lip length on( both cleft and non-cleft side), Nasal width, Total nasal width.; Postoperative (measurements will be taken three months after the surgery). Vertical lip height on( both cleft and non-cleft side), Horizontal lip length on( both cleft and non-cleft side), Nasal width, Total nasal width.	patients were assessed before the operation and followed for 3-4 weeks after.
Secondary	Satisfaction score	by patient parent's satisfaction.	24 hours after the operation
Secondary	Operative time	from the first landmark design to the last suture.	intraoperatively