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

January 15, 2016 updated by: Johan Abeloos, AZ Sint-Jan AV

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruges, Belgium
        • General Hospital Saint-John Bruges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pierre Robin Syndrome (PRS)
Cleft palate patients with the Pierre Robin Syndrome.
non-PRS
Cleft palate patients without the Pierre Robin Syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of peri- and postoperative complications
Time Frame: within 4 weeks postoperative
within 4 weeks postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Johan Abeloos, MD, Maxillofacial surgeon, Head of Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 15, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 15, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B049201525560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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