Cleft Palate Clinical Trial
Official title:
Targeting Surgeons' Decision-Making for Cleft Lip Surgery
NCT number | NCT03537976 |
Other study ID # | 12250 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 31, 2018 |
Est. completion date | August 31, 2025 |
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.
Status | Recruiting |
Enrollment | 48 |
Est. completion date | August 31, 2025 |
Est. primary completion date | August 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Months to 21 Years |
Eligibility | Inclusion Criteria (Lip Revision): - 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 Exclusion Criteria (Lip Revision): - 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 Inclusion Criteria (Lip Repair) - 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 Exclusion Criteria (Lip Repair) - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts University School of Dental Medicine | Boston | Massachusetts |
United States | University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Tufts University | Boston Children's Hospital, Massachusetts General Hospital, Tufts Medical Center, University of Bath, University of North Carolina, Chapel Hill, Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion, an average of 2 years | |
Primary | 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. |
Through study completion, an average of 2 years | |
Secondary | 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. | Through study completion, an average of 2 years | |
Secondary | 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. | Through study completion, an average of 2 years | |
Secondary | 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. | Through study completion, an average of 2 years |
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