Unilateral Cleft Lip Repair : Modified Millard and Mishra Technique

NCT05748340 | Completed DMC

• 1 other identifier: MD-40-2021
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip

Outcome Measures

Primary Outcomes (1)

• Surgical repair unilateral cleft lip measurements

  1. Vertical lip height 2. Horizontal lip length 3. Philtral length

  At 3 months post operative

Study Arms (3)

Control group

OTHER

21normal infant aged 3-6 months

Procedure: Unilateral cleft lip repair

Group a

OTHER

21 patient of unilateral cleft lip had mishra technique repair

Procedure: Unilateral cleft lip repair

Group b

OTHER

21 patient of unilateral cleft lip had modified Millard technique repair

Procedure: Unilateral cleft lip repair

Interventions

Unilateral cleft lip repair PROCEDURE

Surgical repair unilateral cleft lip

Control group; Group a; Group b

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants with unilateral isolated cleft lip aged from 2-6 months
• Infants with incomplete and complete unilateral cleft lip(reach floor of the nose)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine Cairo university

Giza, Cairo Governorate, 11074, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kasr Elainy

  Cairo university Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer pediatric surgery

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 28, 2023
• Study Start: April 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Once publication
• Access Criteria: Open for every one

Locations

EG (1)