Cleft PalateNCT02583100
Improving Outcomes in Cleft Palate Surgery
A study testing Intensive Feedback and Routine Feedback in people with Cleft Palate, run by Children's Hospital Medical Center, Cincinnati at 6 sites in 2 countries.
Trial summary
This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Intensive Feedback and Routine Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2015to Sep 2018
- Phase
- Interventional
- 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
Who may be able to join
- Active surgeon performing cleft palate repair in the US or Canada.
Who cannot join
- none
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Duke Children's Hospital
Durham, North Carolina, 27710
Penn State Hershey Craniofacial Clinic
Hershey, Pennsylvania, 17033
Phoenix Children's Hospital
Phoenix, Arizona, 85013
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons
This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.
Read the detailed description
This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair.
The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons.
The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.
- Conditions
- Cleft Palate
- Being tested
- Intensive Feedback, Routine Feedback
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive FeedbackBehavioural
(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial, (2) receive an analysis of their video-recorded operative technique by surgeon peers, (3) directly observe a peer surgeon with lower fistula rate, and (4) develop a personalized action plan with a target for improvement.
Routine FeedbackBehavioural
(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial
| Study group | Role | What they receive |
|---|---|---|
| Intensive Feedback | Experimental | Participants in this arm will receive intensive feedback on their complication rates, surgical technique, and peri-operative surgical management from peer surgeons participating in the study. Receives: Behavioral: Intensive Feedback |
| Routine Feedback | Active comparator | Participants in this arm will receive routine feedback on their complication rates. Receives: Behavioral: Routine Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oro-nasal Fistula
Presence or absence of fistula of the palate
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Grossoehme, Principal investigator, Children's Hospital Medical Center, CincinnatiThomas Sitzman, MD, Study director, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583100
- Sponsor's protocol ID
- 2015-5428
- Status last verified
- Jun 2021
- First submitted
- 20 Oct 2015
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Cleft Palate Surgery Through an Audit and Feedback Intervention Directed at Surgeons
- ClinicalTrials.gov ID
- NCT02583100
- Acronym / sponsor ID
- 2015-5428
- Conditions
- Cleft Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 21 Oct 2015 (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.
This is a pilot study to determine if an audit and feedback intervention decreases complication rates after cleft palate surgery.
Detailed description
This study will determine whether a surgeon-directed audit and feedback intervention reduces rates of oro-nasal fistula after cleft palate repair. Fistula is an important potential complication of cleft palate repair.
The study also evaluates feasibility of standardized outcome measurement in the care of children with cleft lip and palate, acceptability of standardized measurement, and acceptability of the audit and feedback intervention among surgeons.
The results of this research will improve child health by enabling cleft surgeons to critically evaluate and improve their patient's outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Feedback | Experimental | Behavioral: Intensive FeedbackParticipants in this arm will receive intensive feedback on their complication rates, surgical technique, and peri-operative surgical management from peer surgeons participating in the study. |
| Routine Feedback | Active comparator | Behavioral: Routine FeedbackParticipants in this arm will receive routine feedback on their complication rates. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Active surgeon performing cleft palate repair in the US or Canada.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Feedback(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial, (2) receive an analysis of their video-recorded operative technique by surgeon peers, (3) directly observe a peer surgeon with lower fistula rate, and (4) develop a personalized action plan with a target for improvement. | Behavioural | Intensive Feedback |
| Routine Feedback(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial | Behavioural | Routine Feedback |
Primary outcome
Oro-nasal Fistula
Time frame: 12 weeks
Presence or absence of fistula of the palate
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 24 Jun 2021.
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Furlow With Buccinator and Fistula Formation
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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.
Daniel Grossoehme principal investigator
Children's Hospital Medical Center, Cincinnati
Thomas Sitzman, MD study director
Phoenix Children's Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Feedback and Routine Feedback in people with Cleft Palate, run by Children's Hospital Medical Center, Cincinnati at 6 sites in 2 countries.
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 1 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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?
Oro-nasal Fistula (time frame: 12 weeks). 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 24 Jun 2021; AzTrials last refreshed its copy on 28 Oct 2026.