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Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate : Aesthetic and Functional Impact. (PETROL/TROPHIC)

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ClinicalTrials.gov Identifier: NCT03572907
Recruitment Status : Withdrawn (Investigators decision)
First Posted : June 28, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

The patients in this study are all born with a cleft lip and palate. They underwent several interventions in childhood to take care of it.

Professor Gleizal offered them a secondary rhinoplasty aimed at normalizing the appearance of their nose.

In this malformative and multioperated context, typical nasal deformities affect the tip of the nose, which appears to be sagging and asymmetrical. Scarred soft tissues exert an important retractile force against which conventional rhinoplasty techniques often remain insufficient.

The use of columellar struts makes it possible to give again projection to the tip of the nose but when this strut is made from cartilage or bone, it is absorbed with the time. Moreover, these interventions require a remote removal of the site of interest (costal cartilage, tibial crest, calvaria) which generates additional morbidity.

The investigators propose an alternative using a synthetic graft of titanium. This material has been used for many years for its excellent biocompatibility and trauma resistance.

28 patients were able to benefit from this technique between March 1, 2016 and March 1, 2018.

The investigators wish to evaluate the aesthetic and functional results from the patient's point of view by submitting them to one validated rhinoplasty questionnaire after the end of the patient's inclusion.


Condition or disease Intervention/treatment
Cleft Lip Cleft Palate Other: Rhinoplasty questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Titanium Plate in Rhinoplasty in Patients With Cleft Lip and Palate: Aesthetic and Functional Impact. TROPIC (Titanium RhinOPlasty ImpaCt)
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

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Groups and Cohorts
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Intervention Details:
  • Other: Rhinoplasty questionnaire
    Each patient will complete a validated rhinoplasty questionnaire (Rhinoplasty Outcome Evaluation) before and after the intervention

Outcome Measures
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Primary Outcome Measures :
  1. Rhinoplasty Outcome Evaluation scores [ Time Frame: 1 month ]

    Comparison of pre- and postoperative ROE (Rhinoplasty Outcome Evaluation) scores in patients with cleft lip and palate who benefited from the placement of a titanium columellar strut.

    Each patient completes the questionnaire before and after the intervention. Then the investigators compare these scores to evaluate the improvement.



Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cleft lip and palate who underwent secondary rhinoplasty using a titanium columelar strut between March 1, 2016 and March 1, 2018.
Criteria

Inclusion Criteria:

  • patient over 12 years
  • patients with cleft lip and palate operated by Pr Gleizal of a secondary rhinoplasty using a titanium columellar strut
  • between January 1, 2016 and March 1, 2018
  • patient not having opposed their participation

Exclusion Criteria:

  • patient not mastering the French language
  • patient participating in interventional research
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572907


Locations
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France
Service de chirurgie maxillo-faciale - Hôpital de la Croix Rousse - Groupement Hospitalier Nord - Hospices Civils de Lyon
Lyon, France, 69004
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03572907    
Other Study ID Numbers: 69HCL18_0328
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cleft Palate
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
 Congenital Abnormalities
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities