Comparison of Techniques in Repair of Unilateral Cleft Lip

NCT ID: NCT05080855

Last Updated: 2021-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2020-02-05

Brief 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.

Conditions

Unilateral Cleft Lip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

the cleft lip will be repaired by modified Millard technique

In the modified Millard technique, points (nasal and Vermilion border points) and lines (rotational and advancement flap lines and mucosal lines) were drawn. Then, we cut the submucosal layer and created three flaps: advancement flap, rotational flap, and c flap. The orbicular muscle was dissected and freed from the columellar base on the non-cleft side and from the alar base on the cleft side. Using a vicryl 5-0, we sutured the anterior nasal floor; then, using vicryl 4-0, we sutured the alar base and muscle. Using vicryl 6-0, we sutured top of philtral column with point a, the peak of Cupid's bow, and tip of c flap with alar base. The suturing of mucosal lip was carried out using a vicryl 5-0.

Group Type: ACTIVE_COMPARATOR

modified Millard technique vs Tennison-Randall technique

Intervention Type: PROCEDURE

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.

the cleft lip will be repaired by Tennison-Randall technique.

In the Tennison-Randall technique, points (nasal and Vermilion border points) and lines (Skin triangle flap lines and mucosal lines) were drawn. Then, we cut the submucosal layer and created equilateral triangle flap and releasing incision. The orbicular muscle was dissected and freed from the columellar base on the non-cleft side and from the alar base on the cleft side. The suturing of the anterior nasal floor, alar base, and muscle followed the same principles of the modified Millard technique. The cutaneous repair was done by suturing the top of philtral column, the peak of Cupid's bow, point a, the line between the top of philtral column and the peak of Cupid's bow with b-8 and 3-a with b-a.

Group Type: ACTIVE_COMPARATOR

modified Millard technique vs Tennison-Randall technique

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Salah Ahmed

Faculty of Pediatric Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pediatric Surgery department, Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

150318

Identifier Type: -

Identifier Source: org_study_id