Clinical trial · Observational
Submental Island Flap vs Radial Forearm Free Flap in Tongue Reconstruction
Evaluation of Quality of Life Post Tongue Cancer Resection and Reconstruction Using Submental Island Pedicled Flap Versus Radial Forearm Free Flap
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
| Tongue Carcinoma | Tongue Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tongue Neoplasms | Tongue Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radial Forearm Free Flap (RFFF) | Procedure | — | UNRESOLVED |
| Submental Island Pedicled Flap (SIPF) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- SIPF Group
- description
- Patients who underwent tongue reconstruction using Submental Island Pedicled Flap following tongue cancer resection.
- interventionNames
- Procedure: Submental Island Pedicled Flap (SIPF)
- label
- RFFF group
- description
- Patients who underwent tongue reconstruction using Radial Forearm Free Flap following tongue cancer resection.
- interventionNames
- Procedure: Radial Forearm Free Flap (RFFF)
Primary outcomes (1)
- measure
- 12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)
- timeFrame
- 12 months post operatively
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available