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.
Orofacial clefts affect approximately 6,800 births in the United States each year with an estimated 80% affected with a non-syndromic, sporadic unilateral or bilateral cleft lip and/or palate (CL/P). Our research team, which included surgeons experienced in the care of CL/P children, has developed a novel Intervention approach that utilizes objective dynamic and static measures/quantitative visual aids together with a systematic subjective evaluation to quantify facial disability for treatment planning for lip surgery and to assess surgical outcomes. Using this Intervention, the goals of this Phase II randomized clinical trial are to determine how surgeons integrate the objective measures/ visual aids of the Intervention with their subjective assessment; to determine the extent to which the Intervention changes surgeon?s treatment plan/goals for surgery; and to determine whether surgeons? achieve their surgical goals.
| Trotman, Carroll Ann; Faraway, Julian; Hadlock, Tessa et al. (2018) Quantifying Soft Tissue Shape and Symmetry: Patients with Cleft Lip/Palate and Facial Paralysis. Plast Reconstr Surg Glob Open 6:e1715 |
