Clinical trial NCT03537976: Targeting Surgeons' Decision-Making for Cleft Lip Surgery
Official title: Targeting Surgeons' Decision-Making for Cleft Lip Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cleft Palate
Cleft Lip
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Wake Forest University Health Sciences
name: Boston Children's Hospital
name: Massachusetts General Hospital
name: Tufts Medical Center
name: University of Bath
First posted: 2018-05-25
Enrollment: 48
Sex: ALL
Minimum age (years): 0
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgeon-raters' decision making in lip revision
timeFrame: Through study completion, an average of 2 years
measure: Surgeon-raters' decision making in primary lip repair
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision.
timeFrame: Through study completion, an average of 2 years
measure: The quantitative assessment of the extent to which the SAFS changes surgeons' problem list and treatment planning goals for primary lip repair.
timeFrame: Through study completion, an average of 2 years
measure: 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.
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Tufts University School of Dental Medicine
name: Carroll Ann Trotman
role: PRINCIPAL_INVESTIGATOR
References: