Cleft PalateNCT03537976
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
A study testing Static Images and Facial Videos in people with Cleft Palate and Cleft Lip, run by Tufts University at 2 sites in United States.
Trial summary
Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures and visual aids of the Intervention with the systematic subjective assessment in order to… Read more about this study
- Who is it for?
- Ages 0 months to 21 years
- Conditions the study is for
- Cleft Palate, Cleft Lip
- What is being tested?
- Static Images and Facial Videos
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2018to 31 Aug 2025
- 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 0 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 4 to 21 years
- Presence of a previously repaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate
- The professional clinical recommendation by the craniofacial plastic surgeon for a full or partial thickness lip revision
- Age birth to 8 months
- Presence of an unrepaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate
Who cannot join
- Lip revision surgery within the past two years
- A diagnosis of a craniofacial anomaly other than cleft lip (and palate)
- A medical history of collagen vascular disease, or systemic neurologic impairment
- Mental, visual, or hearing impairment to the extent that comprehension or ability to perform tests associated with the collection of the imaging data is hampered
- A diagnosis of a craniofacial anomaly other than cleft lip (and palate)
- A medical diagnosis of collagen vascular disease, and systemic neurologic impairment
- Mental, visual, or hearing impairment to the extent that the infant's ability to perform tests associated with the collection of the imaging data is hampered
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures and visual aids of the Intervention with the systematic subjective assessment in order to determine decisions surgery.
Read the detailed description
The standard-of-care to evaluate patients for lip revision surgery relies on a subjective assessment by the surgeon of the static face. The important role of function or movement generally has been given far less consideration mainly because of the challenges faced by surgeons (e.g., the amount/quality of the tissue available to alter movement). Presently, even when surgeons do attempt to assess function, they do so in a subjective manner because there are no quantitative/visual aids to incorporate functional assessment into their treatment planning and decisions regarding lip surgery.
The Intervention approach proposed here has been refined sufficiently with surgeon feedback to allow surgeons to broaden their "vista" of the patients' 'movement and form' problems. Potentially, having identified a movement/form problem(s), surgeons could contemplate what needs to be done to improve patient specific problem(s). Importantly, pilot studies demonstrated that the Intervention had a definite impact on surgeons' decisions for lip revision: Surgeons substantially, but variably, changed their problem list and treatment planning goals. Thus, a goal of this study is to collect surgical outcome data which will be used primarily to monitor adverse events but also will provide preliminary information on improvement in patient outcomes (facial form and movement) when surgeons use the Intervention. In addition, given that revision surgery is very common after the primary lip repair, it is important to understand surgeons' decision-making with the use of the Intervention, to determine surgeons' goals and expectations for primary lip repair surgery, and to understand the surgical limitations that may lead to subsequent revision surgery.
- Conditions
- Cleft Palate, Cleft Lip
- Being tested
- Static Images and Facial Videos
- Medical subject headings
- Cleft Palate, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Images and Facial VideosOther
2D and 3D still and video images obtained from each patient before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Static Images and Facial Videos | Other | 2D and 3D still and video images obtained from each patient before surgery. Receives: Other: Static Images and Facial Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon-raters' decision making in lip revision
Outcomes are based on transcribing the In-Depth-Interviews (IDIs) that will be conducted with the surgeon-raters; coding the transcript with an a priori structure in mind (using the interview format as a starting point) but then using Grounded Theory to guide further coding in order to capitalize on themes that emerge that may not conform to the interview format. Themes will be developed (from the interview format and/or the emergent themes) that we will group by frequency as well as to their relevance to hypothesis generation as to how surgeon-raters might learn about and integrate patient data over time.
Measured: Through study completion, an average of 2 years
Surgeon-raters' decision making in primary lip repair
Outcomes are based on transcribing the IDIs that will be conducted with the surgeon-raters; coding the transcript with an a priori structure in mind (using the interview format as a starting point) but then using Grounded Theory to guide further coding in order to capitalize on themes that emerge that may not conform to the structured interview format. Themes will be developed (from the interview format and/or the emergent themes) that we will group by frequency as well as to their relevance to hypothesis generation as to how surgeon-raters might learn about and integrate patient data over time.
This thematic and frequency analysis will be conducted after the SAFS Intervention is conducted with the surgeons for those patients who are in need of lip revision surgery to address objective 1, as well as after the SAFS Intervention is conducted with the surgeons for those patients in need of primary lip repair surgery to address objective 2.
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision.
Nominal outcome of the effect of the SAFS on surgeon-raters' treatment plans/goals in terms of whether the surgeon-rater changes his problem list and goals for lip revision.
Measured: Through study completion, an average of 2 years
The quantitative assessment of the extent to which the SAFS changes surgeons' problem list and treatment planning goals for primary lip repair.
Nominal outcome of the effect of the SAFS on surgeon-raters' treatment plans/goals in terms of whether and how much the surgeon-rater changes his problem list and goals for primary lip repair.
Measured: Through study completion, an average of 2 years
The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision as a function of surgical expertise.
Nominal outcome of the effect of the SAFS on surgeon-raters' treatment plans/goals in terms of whether the surgeon-rater changes his problem list and goals for lip revision based on the length of surgical experience (in years) of treating patients with cleft lip and palate.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start31 Jan 2018
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Wake Forest University Health Sciences, Boston Children's Hospital, Massachusetts General Hospital, Tufts Medical Center, University of Bath
- Responsible party
- Principal investigator, Carroll Ann Trotman, Tufts University
- Investigators
- Carroll Ann Trotman, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537976
- Sponsor's protocol ID
- 12250
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2018
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Surgeons' Decision-Making for Cleft Lip Surgery
- ClinicalTrials.gov ID
- NCT03537976
- Acronym / sponsor ID
- 12250
- Conditions
- Cleft Palate, Cleft Lip
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Wake Forest University Health Sciences, Boston Children's Hospital, Massachusetts General Hospital, Tufts Medical Center, University of Bath
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 25 May 2018 (actual)
- 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.
Using separate prospective cohorts of patients who have lip revision and lip repair surgery, the objective of this clinical trial is to both qualitatively and quantitatively assess how surgeons integrate the objective measures and visual aids of the Intervention with the systematic subjective assessment in order to determine decisions surgery.
Detailed description
The standard-of-care to evaluate patients for lip revision surgery relies on a subjective assessment by the surgeon of the static face. The important role of function or movement generally has been given far less consideration mainly because of the challenges faced by surgeons (e.g., the amount/quality of the tissue available to alter movement). Presently, even when surgeons do attempt to assess function, they do so in a subjective manner because there are no quantitative/visual aids to incorporate functional assessment into their treatment planning and decisions regarding lip surgery.
The Intervention approach proposed here has been refined sufficiently with surgeon feedback to allow surgeons to broaden their "vista" of the patients' 'movement and form' problems. Potentially, having identified a movement/form problem(s), surgeons could contemplate what needs to be done to improve patient specific problem(s). Importantly, pilot studies demonstrated that the Intervention had a definite impact on surgeons' decisions for lip revision: Surgeons substantially, but variably, changed their problem list and treatment planning goals. Thus, a goal of this study is to collect surgical outcome data which will be used primarily to monitor adverse events but also will provide preliminary information on improvement in patient outcomes (facial form and movement) when surgeons use the Intervention. In addition, given that revision surgery is very common after the primary lip repair, it is important to understand surgeons' decision-making with the use of the Intervention, to determine surgeons' goals and expectations for primary lip repair surgery, and to understand the surgical limitations that may lead to subsequent revision surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Static Images and Facial Videos | Other | Other: Static Images and Facial Videos2D and 3D still and video images obtained from each patient before surgery. |
Who may qualify
- Ages
- 0 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 4 to 21 years
- Presence of a previously repaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate
- The professional clinical recommendation by the craniofacial plastic surgeon for a full or partial thickness lip revision
- Age birth to 8 months
- Presence of an unrepaired unilateral or bilateral cleft lip and palate with a complete cleft of the primary palate and at least a partial or complete cleft of the secondary palate
Key exclusion criteria (7 listed)
- Lip revision surgery within the past two years
- A diagnosis of a craniofacial anomaly other than cleft lip (and palate)
- A medical history of collagen vascular disease, or systemic neurologic impairment
- Mental, visual, or hearing impairment to the extent that comprehension or ability to perform tests associated with the collection of the imaging data is hampered
- A diagnosis of a craniofacial anomaly other than cleft lip (and palate)
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 |
|---|---|---|
| Static Images and Facial Videos2D and 3D still and video images obtained from each patient before surgery. | Other | Static Images and Facial Videos |
Primary outcome
Surgeon-raters' decision making in lip revision
Time frame: Through study completion, an average of 2 years
Outcomes are based on transcribing the In-Depth-Interviews (IDIs) that will be conducted with the surgeon-raters; coding the transcript with an a priori structure in mind (using the interview format as a starting point) but then using Grounded Theory to guide further coding in order to capitalize on themes that emerge that may not conform to the interview format. Themes will be developed (from the interview format and/or the emergent themes) that we will group by frequency as well as to their relevance to hypothesis generation as to how surgeon-raters might learn about and integrate patient data over time.
Surgeon-raters' decision making in primary lip repair
Time frame: Through study completion, an average of 2 years
Outcomes are based on transcribing the IDIs that will be conducted with the surgeon-raters; coding the transcript with an a priori structure in mind (using the interview format as a starting point) but then using Grounded Theory to guide further coding in order to capitalize on themes that emerge that may not conform to the structured interview format. Themes will be developed (from the interview format and/or the emergent themes) that we will group by frequency as well as to their relevance to hypothesis generation as to how surgeon-raters might learn about and integrate patient data over time. This thematic and frequency analysis will be conducted after the SAFS Intervention is conducted with the surgeons for those patients who are in need of lip revision surgery to address objective 1, as well as after the SAFS Intervention is conducted with the surgeons for those patients in need of primary lip repair surgery to address objective 2.
3 secondary outcomes
The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision.
Time frame: Through study completion, an average of 2 years
The quantitative assessment of the extent to which the SAFS changes surgeons' problem list and treatment planning goals for primary lip repair.
Time frame: Through study completion, an average of 2 years
The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision as a function of surgical expertise.
Time frame: Through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Carroll Ann Trotman principal investigator
Tufts University School of Dental Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Images and Facial Videos in people with Cleft Palate and Cleft Lip, run by Tufts University at 2 sites in United States.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Results are not available in the source record.
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?
Surgeon-raters' decision making in lip revision (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 28 Aug 2024.