Targeting Surgeons' Decision Making for Lip Revision Surgery

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Principal Investigator: Carroll Ann Trotman, BDS, MA, MS NIDCR Protocol Number: 15-069-E/ NIDCR Grant Number: U01 DE024503 Targeting Surgeons’ Decision-Making for Cleft Lip Surgery PROTOCOL SUMMARY This study includes: (1) A group of surgeon-raters who will review images and quantitative information of patients with Cleft Lip and Palate (CL/P); and (2) Two prospective groups/cohorts of patients with cleft lip/palate (CL/P) – one cohort recommended to have secondary lip revision surgery and another slated to have primary lip repair surgery. The study will assign surgeon-raters to evaluate patients who are scheduled to be treated at another participating study site. Each surgeon-rater will be assigned to hypothetically assess several patients from both cohorts for surgery. Surgeon-raters will use a novel pre-surgical planning system for this evaluation – the Systematic Assessment for Facial Surgery (SAFS) Intervention. Subsequent to each SAFS, surgeon-raters will participate in an In-depth interview (IDI), designed to illuminate the surgeon-raters’ decision making process. This study will determine how the SAFS Intervention affects surgeons’ decision-making and treatment plans for surgery. Objectives: The Primary objectives of this study are: • To qualitatively assess how surgeon-raters integrate the SAFS’s objective measures and visual aids with the SAFS’s systematic subjective assessment in the decision-making process for the clinical surgical procedures of lip revision. • To qualitatively assess how surgeon-raters integrate the SAFS’s objective measures and visual aids with the SAFS’s systematic subjective assessment in the decision-making process for the clinical surgical procedures of primary lip repair. The secondary objectives of this study are: • To quantitatively assess the extent to which the SAFS changes surgeon-raters’ problem list and treatment planning goals for lip revision. • To quantitatively assess the extent to which the SAFS changes surgeon-raters’ problem list and treatment planning goals for primary lip repair. • To quantitatively assess the extent to which the SAFS changes surgeon-raters’ problem list and treatment planning goals for lip revision as a function of surgical expertise.