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Completed

NCT Number: NCT05080855

Comparison of Techniques in Repair of Unilateral Cleft Lip

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.

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Key information

Conditions

Unilateral Cleft Lip

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Surgery department, Cairo University

Cairo, 11311, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with age from 2 months old to 6 months old.
  • Patient with unilateral cleft lip complete or incomplete type.

Exclusion criteria

  • Patient with age less than 2 months old or more than 6 months old.
  • Patients with bilateral cleft lip
  • Patients with recurrent cleft lip.
  • Patients with associated major congenital anomalies like major cardiac anomalies.

Treatment and study plan

modified Millard technique vs Tennison-Randall technique

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.

Primary outcomes

  1. Assessment of Post-operative Complications

    Time frame: 1 month

    Early:

    Wound infection. Wound dehiscence.

    Late:

    Wound scarring. Lip notch

Secondary outcomes

  1. Anthropometry assessment of Cosmetic Results

    Time frame: patients were assessed before the operation and followed for 3-4 weeks after.

    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.

  2. Satisfaction score

    Time frame: 24 hours after the operation

    by patient parent's satisfaction.

  3. Operative time

    Time frame: intraoperatively

    from the first landmark design to the last suture.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 18, 2021
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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