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

Cleft Palate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658318
• Other study ID #: B049201525560
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: January 15, 2016
• Start date: January 2011
• Est. completion date: August 2015

Study information

• Verified date: January 2016
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cleft Palate
• Pierre Robin Syndrome
• Postoperative Complications

Locations

Country	Name	City	State
Belgium	General Hospital Saint-John Bruges	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of peri- and postoperative complications		within 4 weeks postoperative	Yes
Secondary	Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis		within 4 weeks postoperative	No