Intermediate Cleft Rhinoplasty in Unilateral Cleft Lip Patients: Approaches and Outcomes

NCT06127953 | Unknown

• 1 other identifier: Soh-Med-23-10-09MD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective study of 20 patients with unilateral cleft lip nasal deformity. The technique to be performed is open approach intermediate rhinoplasty using a hybrid technique combining Potter, Dibbell, and Tajima methods as needed (Potter 1954, Tajima and Maruyama 1977, Dibbell 1982). Lip revision will be performed with the intermediate cleft rhinoplasty according to the lip deformity if needed. Aim of the work is To propose an algorithmic approach for management of unilateral cleft lip nasal deformity using hybrid techniques of intermediate cleft rhinoplasty and to assess the aesthetic and functional outcomes. All the regulations of the ethical committee of the faculty of medicine in Sohag University will be followed. Each patient will have a private file with a non-disclosure policy at data presentation where all presented data do not contain any personal information specifying the identity of any of the patients. Informed written consent will be taken from all patients in the study. Regarding patients' assessment, the following items will be fulfilled: Full medical and operative history. Complete physical examination. Nasal examination, including nasal analysis, anterior rhinoscopy, Cottle maneuver, modified Cottle maneuver, and possibly endoscopic examination to fully assess any functional problems. Routine laboratory investigations Standard preoperative photographs (frontal, lateral and basal). Surgery follow up will be at 1 week ,1 month, 3 months, 6 months and 1 year and postoperative photographs will be taken.

Conditions

Unilateral Cleft Lip

Keywords

Unilateral Cleft Lip; Cleft Rhinoplasty; Intermediate Cleft Rhinoplasty

Outcome Measures

Primary Outcomes (1)

• measurements of nostril apex height on the cleft lip side.

  Preoperative and postoperative measurements of nostril apex height on the cleft lip side will be compared to determine the effects of surgery on the nasal form.

  1 week then 1, 3, 6 and 12 months post operative date

Secondary Outcomes (1)

• The visual effect of the rhinoplasty.

  1 week then 1, 3, 6 and 12 months post operative date

Study Arms (1)

Unilateral Cleft Lip Patients

OTHER

Study is intermediate cleft rhinoplasty that will be performed in the patients with nasal deformities after repair of unilateral cleft lip congenital anomaly

Procedure: intermediate cleft rhinoplasty

Interventions

intermediate cleft rhinoplasty PROCEDURE

intermediate cleft rhinoplasty using open approach and combined techniques of Tajima, Dibbell and Potter's Rhinoplasty

Unilateral Cleft Lip Patients

Eligibility Criteria

• Age: 1 Year - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with repaired unilateral cleft lip with or without cleft palate with residual nasal deformity.
• Patients aged 1 to 13 years.
• Patients who underwent or did not undergo primary rhinoplasty during the cleft lip repair.

You may not qualify if:

• Patients with bilateral cleft lip.
• Patients who underwent lip/nose revision.
• Patients or parents' refusal to participate in the study.

Sponsors & Collaborators

• Mohamed Elsayed Abdelmonem: lead

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, 82524, Egypt

RECRUITING

Related Publications (5)

• Ayeroff JR, Volpicelli EJ, Mandelbaum RS, Pfaff MJ, Asanad S, Bradley JP, Lee JC. Component Restoration in the Unilateral Intermediate Cleft Tip Rhinoplasty: Technique and Long-Term Outcomes. Plast Reconstr Surg. 2019 Mar;143(3):572e-580e. doi: 10.1097/PRS.0000000000005367.

  PMID: 30601327 BACKGROUND

• Gary C, Sykes JM. Intermediate and Definitive Cleft Rhinoplasty. Facial Plast Surg Clin North Am. 2016 Nov;24(4):487-494. doi: 10.1016/j.fsc.2016.06.017.

  PMID: 27712816 BACKGROUND

• Hoshal SG, Solis RN, Tollefson TT. Controversies in Cleft Rhinoplasty. Facial Plast Surg. 2020 Feb;36(1):102-111. doi: 10.1055/s-0040-1701477. Epub 2020 Mar 19.

  PMID: 32191966 BACKGROUND

• Blackwell SJ, Parry SW, Roberg BC, Huang TT. Onlay cartilage graft of the alar lateral crus for cleft lip nasal deformities. Plast Reconstr Surg. 1985 Sep;76(3):395-401. doi: 10.1097/00006534-198509000-00010.

  PMID: 4034756 BACKGROUND

• Nicksic PJ, Pfaff MJ, Ayeroff JR, Lee JC. Management of the Cleft Nasal Tip: An Overview of Classic Techniques and Strategies. Ann Plast Surg. 2018 May;80(5):581-586. doi: 10.1097/SAP.0000000000001334.

  PMID: 29389706 BACKGROUND

Central Study Contacts

Mohamed Elsayed Abdelmonem, MSc

CONTACT

+201013414134; mohamedelsayedhamad@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Plastic surgery assistant lecturer

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 13, 2023
• Study Start: October 23, 2023
• Primary Completion: October 23, 2024
• Study Completion: January 23, 2025
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)