FDFG Versus SMAS Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
- Conditions
- Frey Syndrome
- Interventions
- Procedure: FDFGProcedure: SMAS
- Registration Number
- NCT05452837
- Lead Sponsor
- Menoufia University
- Brief Summary
After parotidectomy, Frey's syndrome and facial disfigurement are the most common encountered complications. Free dermal fat graft (FDFG) and the superficial musculoaponeurotic system (SMAS) flap, have very promising results. In this study, the functional and esthetic outcome from their usage were compared.
- Detailed Description
Parotidectomy is the standard procedure for treatment of many parotid lesions, however it carries a lot of drawbacks. Facial asymmetry and Frey's syndrome are the most annoying complications to the patients. Insertion of inter-positioning grafts at parotidectomy bed can decrease these complications significantly. Free dermal fat graft (FDFG) and the superficial musculoaponeurotic system (SMAS) flap, have very promising results. In this study the investigators have compared the functional and esthetic outcome from their usage.
Seventy-eight patient underwent parotidectomy for various causes. The patients were divided randomly in 2 groups each group 39 patients. In one group FDFG was inserted at the parotidectomy bed, while in the other group SMAS flap was performed. Preoperative, operative, and postoperative data were recorded and analyzed.
The normality of distribution of variables was verified by Wilks -Shapiro test. The data were expressed as Number (No), percentage (%) mean (x̅) and standard deviation (SD). Chi-square test (χ2) was used to study association between qualitative variables. Whenever any of the expected cells were less than five, Fischer's Exact test was used. Student's t-test is a test of significance used for comparison of quantitative variables between two groups of normally distributed data, while Mann Whitney's test was used for comparison of quantitative variables between two groups of not normally distributed data. Two-sided P value was set to be significant if \< 0.05.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- Patients indicated for superficial parotidectomy
- Less than 18 years of age
- Proved malignant parotid tumor
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Free Dermal Fat Graft FDFG Free Dermal Fat Graft (FDFG) is applied to the superficial parotidectomy defect site Superficial musculoaponeurotic system flap SMAS Superficial musculoaponeurotic system (SMAS) Flap is dissected and tailored to fill the defect after superficial parotidectomy
- Primary Outcome Measures
Name Time Method Number of patients with Frey's syndrome 6 months Number of patients who developed of Frey's syndrome as post-parotidectomy complication
- Secondary Outcome Measures
Name Time Method Degree of patients' satisfaction with the fascial symmetry 6 months Assessment of degree of patients' satisfaction of the esthetic outcome after parotidectomy regarding post parotidectomy facial symmetry based on a verbal descriptive scale; excellent, good, fair, and poor. It is not based on numerical scale.
Number of patients who will have excellent, good, fair or poor response will be recorded and compared within the two groups.
Trial Locations
- Locations (1)
Faculty of Medicine, Menoufia University
🇪🇬Shibīn Al Kawm, Egypt