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Unilateral Cleft LipNCT06127953

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

A study testing intermediate cleft rhinoplasty in people with Unilateral Cleft Lip, run by Mohamed Elsayed Abdelmonem at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 1 year to 13 years
Conditions the study is for
Unilateral Cleft Lip
What is being tested?
intermediate cleft rhinoplasty
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
23 Oct 2023to 23 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Mohamed Elsayed Abdelmonem, MSc contact

+201013414134

mohamedelsayedhamad@gmail.com

Egypt1 site, 1 recruiting
  • Faculty of Medicine Sohag University

    Sohag, 82524

    Magdy M Amin, Professor

    Recruiting

Other trials in Egypt

About this study

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.

Read more

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.

Read the detailed description

Cleft lip and palate is the most common congenital craniofacial abnormality (Jeong, Lee et al. 2012, Yue, Piao et al. 2023). Cleft nasal deformity is the most prominent aesthetic problem in the growing cleft patient after lip repair (Park, Koo et al. 2022). Correction of the residual cleft lip nasal deformity remains a complex and difficult to manage challenge as nasal asymmetry increases with the growth and development of the affected child in addition to the scarring from previous surgeries of the lip and nose (Ayeroff, Volpicelli et al. 2019). The cleft nasal deformity affects all layers of the nose including the bony platform, the inner lining, the cartilaginous infrastructure, and the external skin (Olds and Sykes 2022). The severity of nasal deformity is dependent upon the degree of the original cleft lip abnormality (Gary and Sykes 2016).

There has been a debate for long time regarding the timing of cleft rhinoplasty and there has been a trend to perform it after the age of full maturity. The rationale behind this belief was to avoid interference with nasal growth, however many studies have disproved this traditional idea (Pagan, Sterling et al. 2021) and even in Millard's classic paper, he pointed out that a minor aesthetic correction during childhood is sometimes required (Millard 1964). Cleft rhinoplasties are divided into 3 stages: primary, performed within the first year of life; intermediate, performed prior to completion of facial growth; and definitive, which occurs after skeletal and dental maturity (Ayeroff, Volpicelli et al. 2019).

Intermediate cleft rhinoplasty is defined as any nasal surgery performed between the time of initial cleft lip repair and the time at which the patient reaches facial skeletal maturity (around 15 to 17 years of age in females and in male patients at approximately 16 to 18 years of age) (Gary and Sykes 2016). Intermediate rhinoplasty is indicated in case of functional compromise (nasal obstruction and sleep apnea) as in severe septal deviation and severe alar deformities and in situations of child and parent wishes due to psychological distress from their peers in school age. Some studies have shown that children with orofacial cleft suffer the highest incidence of depression, anxiety, and negative peer relationships around the ages 8 to 10 years (Hoshal, Solis et al. 2020, Olds and Sykes 2022, Park, Koo et al. 2022).

One of the earliest attempts to correct the nasal tip deformity was in 1932 when Gillies and Kilner described the "alar shift" technique, allowing for the advancement of the cleft side columella towards the tip (Wilkie 1969). In 1938, McIndoe was the first surgeon to reposition and fix the cartilage of the cleft side (McIndoe 1938), but Potter in 1954 added the concept of not only repositioning the lower lateral cartilage medially but also the lateral release via an open nasal approach(Potter 1954, Rousso 2015).

In 1964, Millard introduced the concept of additional support using auricular cartilage grafts at 5 years of age with cleft tip revisions (Millard 1964). Tajima and Maruyama in 1977 pointed out that the overhanging alar web is one of the most visible stigmata of cleft noses and this excess skin will result in cartilage malposition and redundancy (Tajima and Maruyama 1977, Nicksic, Pfaff et al. 2018). In 1982, Dibbell described a procedure to address the alar web by rotating and advancing the nostril medially and superiorly in addition to fixation of cleft lower lateral cartilage (Dibbell 1982). Blackwell in 1985 focused on both cartilage reposition and utility of additional support (Blackwell, Parry et al. 1985, Nicksic, Pfaff et al. 2018).

Cutting in 2009 described a technique for tip cleft rhinoplasty which combines an open rhinoplasty with the Dibbell and Tajima techniques (Flores, Sailon et al. 2009). Ayeroff, Volpicelli et al. described the component restoration approach for intermediate cleft rhinoplasty that addresses the three anatomical disturbances of the cleft nasal tip: lower lateral cartilage malpositioning, lower lateral cartilage hypoplasia, and nasal lining deficiency(Ayeroff, Volpicelli et al. 2019). Ohara, Nakajima et al. described the use of the subcutaneous flap technique to address the cleft bulbous nasal tip and define the alar groove through an open rhinoplasty approach (Ohara, Nakajima et al. 2009).

There are conflicting views regarding the use of cartilage grafts in intermediate cleft rhinoplasty. However, recent studies approved their use during the 5- to 13-year age period and found that it was effective in aesthetic and functional outcomes, with a low-risk profile (Ozaki, Chaffoo et al. 2006, Lu, Yao et al. 2017, Zhang, Bai et al. 2018, Pagan, Sterling et al. 2021).

The large number of techniques in the literature to address this challenge is a testament to both the complexity of the task and the limitations of our ability to provide dependable surgical solutions (Hoshal, Solis et al. 2020). Successful surgical correction is often surgeon-dependent and often based on training and experience (Hoshal, Solis et al. 2020). As Dibbell observed in 1982, "Anytime there are many differing attacks on a surgical problem area, the sophisticated practitioner will conclude that none of these approaches are satisfactory" (Dibbell 1982). To date, there is no consensus regarding universal guidelines or the ideal techniques for the management of cleft nasal deformities (Olds and Sykes 2022).

Being tested
intermediate cleft rhinoplasty
Keywords
Unilateral Cleft Lip, Cleft Rhinoplasty, Intermediate Cleft Rhinoplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intermediate cleft rhinoplastyProcedure or surgery

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

Study groups in NCT06127953
Study groupRoleWhat they receive
Unilateral Cleft Lip PatientsOtherStudy is intermediate cleft rhinoplasty that will be performed in the patients with nasal deformities after repair of unilateral cleft lip congenital anomaly
Receives: Procedure: intermediate cleft rhinoplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start23 Oct 2023
  3. Primary completion23 Oct 2024 (estimated)
  4. Study completion23 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06127953
Sponsor's protocol ID
Soh-Med-23-10-09MD
Status last verified
Nov 2023
First submitted
4 Nov 2023
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30601327
  • 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.

    PubMed 27712816
  • 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.

    PubMed 32191966
  • 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.

    PubMed 4034756
  • 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.

    PubMed 29389706

Questions about this trial

What is this clinical trial studying?

A study testing intermediate cleft rhinoplasty in people with Unilateral Cleft Lip, run by Mohamed Elsayed Abdelmonem at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Elsayed Abdelmonem, MSc (+201013414134, mohamedelsayedhamad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

measurements of nostril apex height on the cleft lip side. (time frame: 1 week then 1, 3, 6 and 12 months post operative date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06127953, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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