Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-11 @ 5:25 PM
Study NCT ID:
NCT02658318
Status:
COMPLETED
Last Update Posted:
2016-01-18
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations
Sponsor:
AZ Sint-Jan AV
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: