Quality of Life, Tongue Carcinoma, Tongue Neoplasms
Conditions
Keywords
Submental flap, Radial fore arm flap, Quality of life, Partial tongue resection, Tongue reconstruction
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESubmental Island Pedicled Flap (SIPF)
Surgical reconstruction of tongue defect following oncological resection using a pedicled submental island flap.
PROCEDURERadial Forearm Free Flap (RFFF)
Surgical reconstruction of tongue defect following oncological resection using a microvascular radial forearm free flap.
Sponsors
Al-Azhar University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (aged 18 years or older) diagnosed with squamous cell carcinoma of the tongue requiring partial or total glossectomy. 2. Indication for immediate soft tissue reconstruction using either Submental Island Pedicled Flap (SIPF) or Radial Forearm Free Flap (RFFF). 3. Patients eligible and cleared for major surgical resection and flap reconstruction under general anesthesia. 4. Patient's informed consent to participate in the study and complete follow-up evaluations.
Exclusion criteria
1. History of previous radiation therapy or surgical intervention in the head and neck region. 2. Clinical or radiological evidence of nodal metastasis in level I submental lymph nodes (for SIPF candidates). 3. Severe systemic comorbidities precluding major surgery or prolonged general anesthesia (ASA class IV or higher). 4. Distance or inability to commit to the 12-month postoperative follow-up schedule and quality of life assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4) | 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. |
| Operative time | Day of surgery (intraoperative) | Total duration of surgery measured in hours from initial skin incision to final closure. |
| Length of hospital stay | From date of surgery to hospital discharge. Up to 30 days | Total duration of inpatient hospital admission measured in days from surgery until discharge. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed Serag Attia, MSc
Al-Azhar University
Outcome results
None listed