Targeting Surgeons' Decision-Making for Cleft Lip Surgery

Tufts University

Status

Active, not recruiting

Conditions

Cleft Lip

Cleft Palate

Treatments

Other: Static Images and Facial Videos

Study type

Interventional

Funder types

Other

Identifiers

NCT03537976

12250

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 estimated patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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