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Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations

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ClinicalTrials.gov Identifier: NCT02658318
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Johan Abeloos, AZ Sint-Jan AV

Study Description
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Brief Summary:

In cleft surgery there is no current general agreement on the treatment strategy of patients with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on the treating physician or the hospital facility. Literature regarding peri- and postoperative complications in the target population are lacking.

The investigators aim to retrospectively review the charts of all cleft patients, both PRS and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015. The incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. The value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.


Condition or disease
Pierre Robin Syndrome Cleft Palate

Study Design
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Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Study Start Date : January 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

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Groups and Cohorts
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Group/Cohort
Pierre Robin Syndrome (PRS)
Cleft palate patients with the Pierre Robin Syndrome.
non-PRS
Cleft palate patients without the Pierre Robin Syndrome.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of peri- and postoperative complications [ Time Frame: within 4 weeks postoperative ]

Secondary Outcome Measures :
  1. Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis [ Time Frame: within 4 weeks postoperative ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All cleft patients consecutively treated with a modified Furlow palatoplasty between 01/01/2011 and 31/08/2015 in the Department of Oral and Maxillofacial Surgery of the General Hospital Saint-John Bruges (Bruges, Belgium) or the Department of Pediatrics of the Semmelweis University (Budapest, Hungary)
Criteria

Inclusion Criteria:

  • patients of all ages
  • patients that had undergone a modified Furlow palatoplasty
  • patients treated at the GH Saint-John Bruges (Belgium), or the cooperating Semmelweis University (Hungary)

Exclusion Criteria:

  • patients not eligible according to the abovementioned criteria
Contacts and Locations
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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): NCT02658318


Locations
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Belgium
General Hospital Saint-John Bruges
Bruges, Belgium
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Johan Abeloos, MD Maxillofacial surgeon, Head of Department
More Information
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Responsible Party: Johan Abeloos, Maxillofacial surgeon, Head of Department, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT02658318    
Other Study ID Numbers: B049201525560
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johan Abeloos, AZ Sint-Jan AV:
peri- and postoperative complications
airway obstruction
adapted Furlow palatoplasty
Additional relevant MeSH terms:
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Cleft Palate
Pierre Robin Syndrome
Postoperative Complications
Pathologic Processes
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
 Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Mouth Abnormalities
Mouth Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities