Targeting Surgeons' Decision-Making for Cleft Lip Surgery

NCT03537976 | Active Not Recruiting

• 1 other identifier: 12250
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Cleft Palate; Cleft Lip

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• The quantitative assessment of the extent to which the SAFS changes surgeon-raters' problem list and treatment planning goals for lip revision.

  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.

  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.

  Through study completion, an average of 2 years

Study Arms (1)

Static Images and Facial Videos

OTHER

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

Other: Static Images and Facial Videos

Interventions

Static Images and Facial Videos OTHER

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

Static Images and Facial Videos

Eligibility Criteria

• Age: 0 Months - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Tufts University: lead
• University of North Carolina, Chapel Hill: collaborator
• Wake Forest University Health Sciences: collaborator
• Boston Children's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Tufts Medical Center: collaborator
• University of Bath: collaborator

Study Sites (2)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Cleft Palate; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases

Study Officials

• Carroll Ann Trotman

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: May 25, 2018
• Study Start: January 31, 2018
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)