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Effectiveness of Rotation-advancement and Straight-line Surgical Approaches in Repairing Unilateral Cleft Lip Defect

Comparison of Rotation- Advancement and Straight-line Methods for Repairing of Unilateral Cleft Lip (Randomized Controlled Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04607213
Enrollment
12
Registered
2020-10-29
Start date
2019-11-13
Completion date
2020-10-01
Last updated
2020-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Cleft Lip

Brief summary

compare different effects of Rotation-advancement based on the Millard technique and Straight-line based on Fisher modification as surgical approaches in repairing lip defect of unilateral cleft lip patients.

Detailed description

Twelve participants with unilateral cleft lip equally divided into two groups. Both groups were photographed preoperative and postoperative. The Control group treated using (Rotation-advancement) based on the Millard technique; and the test group treated using (Straight-line) technique based on Fisher modification.

Interventions

PROCEDUREAdvancement-rotation approach based on Millard' for repairing lip defect.

patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; cut- as- you-go by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill.

PROCEDUREStraight-line approach

patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap. On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar.

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Years
Healthy volunteers
No

Inclusion criteria

* Have complete unilateral cleft lip * from birth to 4 years old

Exclusion criteria

* syndromic cleft patient

Design outcomes

Primary

MeasureTime frameDescription
change in vertical and horizontal lip lengthat 3rd, 6th monthsMeasuring vertical and horizontal lip length of the constructed philtral ridge by caliper
change in lip defectat 1st, 3rd and 6th monthsrepaired lip is evaluated by direct visual inspection for the patient evaluation.

Secondary

MeasureTime frameDescription
change in degree of labial scaringat 3rd, 6th monthsUsing a five-point scale based on Asher-McDade scoring system: (very good, good, fair, poor, very poor on a scale of 1-5, where 5 represents very poor and 1 represent very good).
change in nasal symmetryat 3rd, 6th monthsmeasuring total nasal width and nostril width by caliper

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026