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

NCT ID: NCT02658318

Last Updated: 2016-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pierre Robin Syndrome Cleft Palate

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Pierre Robin Syndrome (PRS)

Cleft palate patients with the Pierre Robin Syndrome.

No interventions assigned to this group

non-PRS

Cleft palate patients without the Pierre Robin Syndrome.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Johan Abeloos

Maxillofacial surgeon, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan Abeloos, MD

Role: PRINCIPAL_INVESTIGATOR

Maxillofacial surgeon, Head of Department

Locations

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General Hospital Saint-John Bruges

Bruges, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B049201525560

Identifier Type: -

Identifier Source: org_study_id

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