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

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.

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Key information

Conditions

Pierre Robin Syndrome Airway Obstruction Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Saint-John Bruges

Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Incidence of peri- and postoperative complications

Time frame: within 4 weeks postoperative

Secondary outcomes

Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis

Time frame: within 4 weeks postoperative

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Jan 18, 2016
Registry last updated: Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed