Quality of Life (QOL)of oral cancer patients receiving free fibula flap(FFF)for the reconstruction of anterior mandibular defects: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- NA
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome is quality of life at 6 months by measuring mean (SD) composite physical function score of UW-QOL tool
研究概览
简要总结
Oral cancer is a common cancer in our country. Majority of them present with advanced disease necessitating multimodality treatment of surgery followed by radiotherapy or chemoradiotherapy. Patients with tumors involving the alveolus most often require a
segmental mandibulectomy as part of the treatment. Segmental Mandibulectomy adversely affects a patient’s quality of life to a varying degree, causing significant defects in the Head & Neck region impacting facial appearance and functions of speech,
malocclusion, mastication, swallowing and health-related quality of life. The most challenging procedure is the reconstruction following the resection of any tumor resulting in an anterior segmental mandibulectomy defect. Patients who have undergone free fibula flap are assumed to have a better quality of life and functional outcomes in terms of speech, swallowing, and aesthetic outcomes. There is no prospective study to assess the Quality of life (QQL)in patients who have undergone free Fibula Flap for anterior Mandibular defects. This would be the first prospective study that attempts to assess the quality of life (using Quality of life questionnaires) in oral cancer patients undergoing free fibula flap for Anterior Mandibular defects. The Study hypothesis is that the composite physical function score of patients with anterior mandibular defects with free fibula bone flap are good at 6 months. The objective primarily is to assess the Quality of life of oral cancer patients who have undergone the reconstruction of the anterior mandibular defects with the free Fibula flap in terms of the difference in Composite Physical Function score of the UW-QOL tool at 6 months and secondarily to assess the Quality of life in terms of Duration of Tracheostomy Tube and feeding tube retained at 6 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Treatment Naïve patients with oral cavity squamous cell carcinoma
- •Requiring anterior mandibular resection with midline mandibular defect (resection including both canines or one/both angles of mandible)
- •Age more than 18 years
- •Willing to give the consent
- •Conversant with Hindi, Marathi,or English.
排除标准
- •1.Any significant comorbidity affecting the procedure being done under general anesthesia at the discretion of the operating surgeon.
- •2.Reconstruction done with other flaps such as Pectoralis Major Myocutaneous Flap/Thoracodorsal Artery Perforator Flap.
结局指标
主要结局
Primary outcome is quality of life at 6 months by measuring mean (SD) composite physical function score of UW-QOL tool
时间窗: Baseline: Patients will complete UW-QOL v4 and EQ-5D-5L questionnaires, along with a swallowing assessment. | 4-8 weeks post-surgery: Patients will again complete the UW-QOL v4, EQ-5D-5L, and undergo a swallowing assessment. | 6 months post-surgery: The same questionnaires and swallowing assessment will be administered. | 12 months post-surgery: Final follow-up with UW-QOL v4, EQ-5D-5L, and swallowing assessment will be done
次要结局
- The secondary outcome is to assess the quality of life in terms of duration of tracheostomy tube and feeding tube retained at 6 months(6 months)
研究者
Dr Shivakumar Thiagarajan
Tata Memorial Hospital, Parel, Mumbai