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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02658318

Enrollment

Registered

2016-01-18

Start date

2011-01-31

Completion date

2015-08-31

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Palate, Pierre Robin Syndrome

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of peri- and postoperative complications	within 4 weeks postoperative

Secondary

Measure	Time frame
Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis	within 4 weeks postoperative

Countries

Belgium

Outcome results