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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06127953
Other study ID # Soh-Med-23-10-09MD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 23, 2023
Est. completion date January 23, 2025

Study information

Verified date November 2023
Source Sohag University
Contact Mohamed Elsayed Abdelmonem, MSc
Phone +201013414134
Email mohamedelsayedhamad@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Faculty of Medicine Sohag University Sohag

Sponsors (1)

Lead Sponsor Collaborator
Mohamed Elsayed Abdelmonem

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The visual effect of the rhinoplasty. The visual effect of the operation will also be assessed according to the Global Aesthetic Improvement Scale (GAIS) which is a simple five-point scale to be determined by the patient or patient's parents for assessing global aesthetic improvement in appearance of the nose compared to pretreatment. The five points are: "1" is very much improved, "2" is much improved, "3" is improved, "4" is no change and "5" is worse. 1 week then 1, 3, 6 and 12 months post operative date
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