Faculty of Dental Medicine, Al-Azhar University (Assiut Branch)
Asyut, Assuit, Egypt
NCT Number: NCT07819617
This study evaluates and compares the postoperative surgical outcomes and quality of life (QoL) in patients undergoing tongue reconstruction after tongue cancer resection, comparing two reconstructive options: the Submental Island Pedicled Flap (SIPF) and the Radial Forearm Free Flap (RFFF). Quality of life was assessed using the University of Washington Quality of Life questionnaire (UW-QOL v4) to evaluate functional, cosmetic, and psychological recovery.
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Notify Me18 year and older
All sexes
Observational
Asyut, Assuit, Egypt
Surgical reconstruction following tongue cancer resection is essential for restoring oral function, speech, swallowing, and facial aesthetics. The Radial Forearm Free Flap (RFFF) is widely considered a gold standard for soft tissue oral reconstruction; however, it requires microvascular expertise and carries donor-site morbidity. The Submental Island Pedicled Flap (SIPF) serves as an alternative, offering a reliable regional pedicled flap with local color match and simplified surgical execution without requiring microvascular anastomoses.
This retrospective observational cohort study aims to compare patients who received SIPF versus RFFF for tongue reconstruction. The primary objective is to evaluate health-related quality of life outcomes using the validated University of Washington Quality of Life Questionnaire version 4 (UW-QOL v4), alongside evaluating postoperative surgical outcomes and donor site morbidity.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical reconstruction of tongue defect following oncological resection using a pedicled submental island flap.
Surgical reconstruction of tongue defect following oncological resection using a microvascular radial forearm free flap.
Time frame: 12 months post operatively
Unweighted composite score calculated as the mean of all 12 domains of the University of Washington Quality of Life Questionnaire version 4 (UW-QOL v4), evaluated at 12 months postoperatively and adjusted for baseline composite score using analysis of covariance (ANCOVA). Scores range from 0 to 100, where higher scores indicate better quality of life.
Time frame: 6 months post operatively
Unweighted composite score of the 12 UW-QOL v4 domains evaluated at 6 months postoperatively and adjusted for baseline composite score using ANCOVA. Scores range from 0 to 100.
Time frame: Day of surgery (intraoperative)
Total duration of surgery measured in hours from initial skin incision to final closure.
Time frame: From date of surgery to hospital discharge. Up to 30 days
Total duration of inpatient hospital admission measured in days from surgery until discharge.
Al-Azhar University
Other
Evaluation of Quality of Life Post Tongue Cancer Resection and Reconstruction Using Submental Island Pedicled Flap Versus Radial Forearm Free Flap
Acronym: SIPF-RFFF
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