Evaluation of Quality of Life Post Tongue Cancer Resection and Reconstruction Using Submental Island Pedicled Flap Versus Radial Forearm Free Flap
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged 18 years or older) diagnosed with squamous cell carcinoma of the tongue requiring partial or total glossectomy.
- •Indication for immediate soft tissue reconstruction using either Submental Island Pedicled Flap (SIPF) or Radial Forearm Free Flap (RFFF).
- •Patients eligible and cleared for major surgical resection and flap reconstruction under general anesthesia.
- •Patient's informed consent to participate in the study and complete follow-up evaluations.
排除标准
- •History of previous radiation therapy or surgical intervention in the head and neck region.
- •Clinical or radiological evidence of nodal metastasis in level I submental lymph nodes (for SIPF candidates).
- •Severe systemic comorbidities precluding major surgery or prolonged general anesthesia (ASA class IV or higher).
- •Distance or inability to commit to the 12-month postoperative follow-up schedule and quality of life assessments.
研究组 & 干预措施
SIPF Group
Patients who underwent tongue reconstruction using Submental Island Pedicled Flap following tongue cancer resection.
干预措施: Submental Island Pedicled Flap (SIPF) (Procedure)
RFFF group
Patients who underwent tongue reconstruction using Radial Forearm Free Flap following tongue cancer resection.
干预措施: Radial Forearm Free Flap (RFFF) (Procedure)
结局指标
主要结局
12-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)
时间窗: 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.
次要结局
- 6-Month Baseline-Adjusted Composite Quality of Life (UW-QOL v4)(6 months post operatively)
- Operative time(Day of surgery (intraoperative))
- Length of hospital stay(From date of surgery to hospital discharge. Up to 30 days)
研究者
Mohamed Serag Eldin Attia
Principal investigator
Al-Azhar University