deltatrials
Unknown NA INTERVENTIONAL 1-arm NCT03891719

Correction of the Unilateral Cleft Lip Nasal Deformity With Sliding Chondrocutaneous Flap and Autologous Cartilage Graft

Correction of the Unilateral Cleft Lip Nasal Deformity Using Sliding Chondrocutaneous Flap, Caudal Septal Extension Graft and Auricular Cartilage Graft

Sponsor: Gia Dinh People Hospital

Updated 9 times since 2019 Last updated: Feb 8, 2021 Started: Jul 1, 2019 Primary completion: Dec 31, 2022 Completion: Nov 30, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03891719, this NA trial focuses on Cleft Lip, Unilateral and remains ongoing. Sponsored by Gia Dinh People Hospital, it has been updated 9 times since 2019, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

For the majority of cleft patients, surgeons usually delay secondary rhinoplasty to ages 14 to 16 years for females and 16 to 18 years for males until after completion of nasal growth Unilateral secondary cleft nasal deformity results from hypoplastic nasal tissue, asymmetric growth due to impaired growth, and surgical scarring. The most common deformities include caudal septal deviation, retrodisplacement and under-projection of dome, lateral slumping of the medial crus of the lower lateral cartilage, alar-columellar web, insufficiency of vestibular skin and deficiency of nasal floor. Moreover, these deformities have negative effect on human well-being and quality of life. Despite the opinions on how to address the problems, it seems clear that repositioning and reshaping of the cleft-side cartilages is necessary for restoring form and function. In general, in order to there are two basic approaches: those techniques that move the cleft-side lower lateral cartilage from medial to lateral, and those that move the lower lateral cartilage from lateral to medial. In an effort to correct the vestibular lining deficiency, easily be adapted to combine Tajima's reverse-U incisions for treatment of alar hooding, need for other structural grafts, sliding chondrocutaneous flap offers many advantages. However, in order to improve nasal...

For the majority of cleft patients, surgeons usually delay secondary rhinoplasty to ages 14 to 16 years for females and 16 to 18 years for males until after completion of nasal growth Unilateral secondary cleft nasal deformity results from hypoplastic nasal tissue, asymmetric growth due to impaired growth, and surgical scarring. The most common deformities include caudal septal deviation, retrodisplacement and under-projection of dome, lateral slumping of the medial crus of the lower lateral cartilage, alar-columellar web, insufficiency of vestibular skin and deficiency of nasal floor. Moreover, these deformities have negative effect on human well-being and quality of life.

Despite the opinions on how to address the problems, it seems clear that repositioning and reshaping of the cleft-side cartilages is necessary for restoring form and function. In general, in order to there are two basic approaches: those techniques that move the cleft-side lower lateral cartilage from medial to lateral, and those that move the lower lateral cartilage from lateral to medial. In an effort to correct the vestibular lining deficiency, easily be adapted to combine Tajima's reverse-U incisions for treatment of alar hooding, need for other structural grafts, sliding chondrocutaneous flap offers many advantages. However, in order to improve nasal tip position or columella shape through modification of either the anterior septal and/or posterior septal angle position and to act as the fundamental attachment for sliding lower lateral cartilage, Caudal septal extension and Columellar strut graft play an important role to stabilize the nasal tip.

Besides, with the aim of making it harmonize better with other facial features, dorsal augmentation is needed for improving the shape of the nose. Selecting the optimal material continues to be a challenge. For most surgeons, an autogenous cartilage graft is the first choice in rhinoplasty because of its resistance to infection and resorption.

We assess the functional and aesthetic outcomes based on three criteria:

1. Change in nose symmetry and nasal height (Preoperative and postoperative photographic analyses) 2. Change in functional outcomes through subjective and objective measurement (Questionaire and acoustic rhinometry) 3. Change in Quality of life (Rhinoplasty Outcome Evaluation Questionaire)

Status Flow

~Apr 2019 – ~Sep 2019 · 5 months · monthly snapshotNot Yet Recruiting~Sep 2019 – ~Jan 2021 · 16 months · monthly snapshotRecruiting~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshotRecruiting~Mar 2021 – ~Oct 2021 · 7 months · monthly snapshotRecruiting~Oct 2021 – ~Dec 2023 · 26 months · monthly snapshotRecruiting~Dec 2023 – ~Jul 2024 · 7 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – present · 19 months · monthly snapshotUnknown~Jan 2026 – present · 3 months · monthly snapshotUnknown

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Unknown NA

  2. Sep 2024 — Present [monthly]

    Unknown NA

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown NA

    Status: Unknown StatusUnknown

  4. Dec 2023 — Jul 2024 [monthly]

    Unknown Status NA

    Status: RecruitingUnknown Status

  5. Oct 2021 — Dec 2023 [monthly]

    Recruiting NA

Show 4 earlier versions
  1. Mar 2021 — Oct 2021 [monthly]

    Recruiting NA

  2. Jan 2021 — Mar 2021 [monthly]

    Recruiting NA

  3. Sep 2019 — Jan 2021 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  4. Apr 2019 — Sep 2019 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gia Dinh People Hospital
  • University of Medicine and Pharmacy at Ho Chi Minh City
Data source: University of Medicine and Pharmacy at Ho Chi Minh City

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations