Targeting Surgeons' Decision-Making for Cleft Lip Surgery

NCT ID: NCT03537976

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-31
• Study Completion Date: 2025-08-31

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.

Conditions

Cleft Palate; Cleft Lip

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Static Images and Facial Videos

2D and 3D still and video images obtained from each patient before surgery.

Group Type: OTHER

Static Images and Facial Videos

Intervention Type: OTHER

2D and 3D still and video images obtained from each patient before surgery.

Interventions

Static Images and Facial Videos

2D and 3D still and video images obtained from each patient before surgery.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: collaborator

Boston Children's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Carroll Ann Trotman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carroll Ann Trotman

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Dental Medicine

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

12250

Identifier Type: -

Identifier Source: org_study_id