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Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique

NCT ID: NCT05748340

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Cleft Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

21normal infant aged 3-6 months

Group Type OTHER

Unilateral cleft lip repair

Intervention Type PROCEDURE

Surgical repair unilateral cleft lip

Group a

21 patient of unilateral cleft lip had mishra technique repair

Group Type OTHER

Unilateral cleft lip repair

Intervention Type PROCEDURE

Surgical repair unilateral cleft lip

Group b

21 patient of unilateral cleft lip had modified Millard technique repair

Group Type OTHER

Unilateral cleft lip repair

Intervention Type PROCEDURE

Surgical repair unilateral cleft lip

Interventions

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Unilateral cleft lip repair

Surgical repair unilateral cleft lip

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Khaled Salah Ahmed

Lecturer pediatric surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kasr Elainy

Role: PRINCIPAL_INVESTIGATOR

Cairo university Egypt

Locations

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Faculty of medicine Cairo university

Giza, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MD-40-2021

Identifier Type: -

Identifier Source: org_study_id