Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique
Primary Purpose
Cleft Lip
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Unilateral cleft lip repair
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip
Eligibility Criteria
Inclusion Criteria: Infants with unilateral isolated cleft lip aged from 2-6 months Infants with incomplete and complete unilateral cleft lip(reach floor of the nose) Exclusion Criteria: Infants less than 2 months or more than 6 months Bilateral cleft lip patients Recurrent repair cleft lip cases Facial cleft cases 5-Syndromic patients cases
Sites / Locations
- Faculty of medicine Cairo university
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Control group
Group a
Group b
Arm Description
21normal infant aged 3-6 months
21 patient of unilateral cleft lip had mishra technique repair
21 patient of unilateral cleft lip had modified Millard technique repair
Outcomes
Primary Outcome Measures
Surgical repair unilateral cleft lip measurements
Vertical lip height
Horizontal lip length
Philtral length
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05748340
Brief Title
Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique
Official Title
Comparative Study Between Modified Millard and Mishra Technique in Unilateral Cleft Lip Repair: a Randomised Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our study findings show that vertical lip length and philtral lip height significantly longer in Millard group than Mishra group in immediate postoperative assessment and nasal width was significantly wider in Mishra group than Millard in 3-month postoperative assessment, This may be attributed to that Mishra group deformity was more severe. The lip shape, the vermilion shape was better in Millard technique than Mishra technique, however, this was statistically insignificant The scar shape was less evident in Mishra technique than Millard technique. But this was also statistically insignificant. However, no major difference in the overall results between the Mishra and Millard rotationadvancement repairs. Thus, either technique could be used for unilateral clefts, as the goal of cleft lip repair is making a symmetrical lip with minimal scar restoring the normal appearance of the face and functional anatomy Anthropometric Measurement of surgical outcome evaluates the surgical technique used and helps to compare between cleft and non-cleft side showing the degree of deformity and we used Subjective assessment to analyse facial aesthetics and appearance impairment as the harmony of a person's face is as Important as measurements, so they should be used together in our opinion.
Detailed Description
Cleft lip and palate, which affects 0.5-1.6 out of every 1000 live births, is the most prevalent congenital defect of the head and neck .
When the palatal shelves and the medial nasal process fail to fuse together between the fourth and eighth weeks of development, unilateral cleft lip and palate results . Lip muscles are disrupted and abnormally inserted to the columellar base on the non-cleft side and from the alar base on the cleft side. The nasal floor and alveolus on the cleft side may be deficient or absent. Several approaches, including quadrangular flaps, triangular flaps, and rotationadvancement procedures, were established in the middle of the twentieth century White Roll Vermilion Turn Down Flap (WRV flap) from the lateral lip element Making a symmetrical lip with a small scar and restoring the face's natural appearance and functional structure are the objectives of cleft lip repair . Over the past century, numerous surgical repair approaches have been developed The first known cleft-lip repair was a straight-line suture and a simple cut along the cleft borders, followed by a curved incision to lengthen the lip Drawbacks of straight-line restorations included vertical scar contracture and lip notching Tennison-triangular Randall's approach, which relies on mathematical calculations and lessens vertical lip contraction, is the most popular triangular technique, however the scar violates the philtrum.The Millard rotation-advancement approach was created to align the scar with the philtral column naturally occurring. The initial rotation-advancement technique underwent various variations. Vermilion notching and a scar along the philtral line can be noticed in Millard's repair. The Cupid's bow is distorted and the white roll up is pulled up by scar contracture. was employed by Mishra to modify Millard's technique to create the vermilion and white roll on the medial lip segment. If there is medial hypoplastic vermilion or partial medial vermilion loss, the Mishra procedure is also used Anthropometric Evaluation of surgical technique and comparison of cleft and non-cleft sides are two benefits of measuring surgical outcome .Farkas and colleagues, provided normative measurements of the lip and nose. Qualitative Assessment is subjective assessment and can analyze facial aesthetics and appearance impairment using scales, indices, scoring systems, and rankings. Both direct and indirect techniques can be used to perform anthropometric measurements and qualitative assessments. The most accurate anthropometric method is direct anthropometry, which is the gold standard but requires general anesthesia in young kids. Two dimensional (2D) images can be used for indirect anthropometry; however, calibration and image distance standardization are needed for linear measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
21normal infant aged 3-6 months
Arm Title
Group a
Arm Type
Other
Arm Description
21 patient of unilateral cleft lip had mishra technique repair
Arm Title
Group b
Arm Type
Other
Arm Description
21 patient of unilateral cleft lip had modified Millard technique repair
Intervention Type
Procedure
Intervention Name(s)
Unilateral cleft lip repair
Intervention Description
Surgical repair unilateral cleft lip
Primary Outcome Measure Information:
Title
Surgical repair unilateral cleft lip measurements
Description
Vertical lip height
Horizontal lip length
Philtral length
Time Frame
At 3 months post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Infants with unilateral isolated cleft lip aged from 2-6 months
Infants with incomplete and complete unilateral cleft lip(reach floor of the nose)
Exclusion Criteria:
Infants less than 2 months or more than 6 months
Bilateral cleft lip patients
Recurrent repair cleft lip cases
Facial cleft cases 5-Syndromic patients cases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kasr Elainy
Organizational Affiliation
Cairo university Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Cairo university
City
Giza
State/Province
Cairo
ZIP/Postal Code
11074
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Shared for every one
IPD Sharing Time Frame
Once publication
IPD Sharing Access Criteria
Open for every one
Learn more about this trial
Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique
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