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Comparison of Techniques in Repair of Unilateral Cleft Lip

Primary Purpose

Unilateral Cleft Lip

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
modified Millard technique vs Tennison-Randall technique
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Cleft Lip

Eligibility Criteria

2 Months - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pediatric Surgery department, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

the cleft lip will be repaired by modified Millard technique

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Assessment of Post-operative Complications
Early: Wound infection. Wound dehiscence. Late: Wound scarring. Lip notch

Secondary Outcome Measures

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.
Satisfaction score
by patient parent's satisfaction.
Operative time
from the first landmark design to the last suture.

Full Information

First Posted
September 28, 2021
Last Updated
October 4, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05080855
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Cleft Lip

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the cleft lip will be repaired by modified Millard technique
Arm Type
Active Comparator
Arm Description
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.
Arm Title
the cleft lip will be repaired by Tennison-Randall technique.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
modified Millard technique vs Tennison-Randall technique
Intervention Description
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 Outcome Measure Information:
Title
Assessment of Post-operative Complications
Description
Early: Wound infection. Wound dehiscence. Late: Wound scarring. Lip notch
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Anthropometry assessment of Cosmetic Results
Description
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.
Time Frame
patients were assessed before the operation and followed for 3-4 weeks after.
Title
Satisfaction score
Description
by patient parent's satisfaction.
Time Frame
24 hours after the operation
Title
Operative time
Description
from the first landmark design to the last suture.
Time Frame
intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Pediatric Surgery department, Cairo University
City
Cairo
ZIP/Postal Code
11311
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Techniques in Repair of Unilateral Cleft Lip

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