Clinical trial NCT05080855: Comparison of Techniques in Repair of Unilateral Cleft Lip
Official title: Unilateral Cleft Lip Repair: Quantitative (Anthropometric) Comparative Assessment of Modified Millard vs Tennison-Randall Techniques.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unilateral Cleft Lip
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Assessment of Post-operative Complications
timeFrame: 1 month
Secondary outcomes:
measure: Anthropometry assessment of Cosmetic Results
timeFrame: patients were assessed before the operation and followed for 3-4 weeks after.
measure: Satisfaction score
timeFrame: 24 hours after the operation
measure: Operative time
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Pediatric Surgery department, Cairo University
Study officials:
References: