Pierre Robin SyndromeNCT02658318
Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations
An observational study of Pierre Robin Syndrome and Cleft Palate, run by AZ Sint-Jan AV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pierre Robin Syndrome, Cleft Palate
- How many people
- 92 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- patients not eligible according to the abovementioned criteria
Trial locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Pierre Robin Syndrome, Cleft Palate, Postoperative Complications, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pierre Robin Syndrome (PRS) | Cleft palate patients with the Pierre Robin Syndrome. | |
| non-PRS | Cleft palate patients without the Pierre Robin Syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peri- and postoperative complications
Measured: within 4 weeks postoperative
Secondary outcomes (1)
Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis
Measured: within 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startJan 2011
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pierre Robin SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, Principal investigator, Maxillofacial surgeon, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658318
- Sponsor's protocol ID
- B049201525560
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations
- ClinicalTrials.gov ID
- NCT02658318
- Acronym / sponsor ID
- B049201525560
- Conditions
- Pierre Robin Syndrome, Cleft Palate
- Keywords
- peri- and postoperative complications, airway obstruction, adapted Furlow palatoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pierre Robin Syndrome (PRS) | – | –Cleft palate patients with the Pierre Robin Syndrome. |
| non-PRS | – | –Cleft palate patients without the Pierre Robin Syndrome. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- patients not eligible according to the abovementioned criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of peri- and postoperative complications
Time frame: within 4 weeks postoperative
1 secondary outcome
Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis
Time frame: within 4 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Individual participant dataSharing planned: No
Related trials for Pierre Robin Syndrome
Active, not recruitingObservational study
3D-CT-Based Prediction of Difficult Laryngoscopy in Infants With Pierre Robin Sequence
Pierre Robin Sequence (PRS), Difficult Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Abeloos, MD principal investigator
Maxillofacial surgeon, Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pierre Robin Syndrome and Cleft Palate, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of peri- and postoperative complications (time frame: within 4 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.