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

NCT02658318 | Completed

• 1 other identifier: B049201525560
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Pierre Robin Syndrome; Cleft Palate

Keywords

peri- and postoperative complications; airway obstruction; adapted Furlow palatoplasty

Outcome Measures

Primary Outcomes (1)

• Incidence of peri- and postoperative complications

  within 4 weeks postoperative

Secondary Outcomes (1)

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

  within 4 weeks postoperative

Study Arms (2)

Pierre Robin Syndrome (PRS)

Cleft palate patients with the Pierre Robin Syndrome.

non-PRS

Cleft palate patients without the Pierre Robin Syndrome.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• patients not eligible according to the abovementioned criteria

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

General Hospital Saint-John Bruges

Bruges, Belgium

Location

MeSH Terms

Conditions

Pierre Robin Syndrome; Cleft Palate; Postoperative Complications; Airway Obstruction

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mouth Abnormalities; Mouth Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Johan Abeloos, MD

  Maxillofacial surgeon, Head of Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial surgeon, Head of Department

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 18, 2016
• Study Start: January 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 18, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)