Comprehensive Pre & Post Operative Functional Assessment of Carcinoma Tongue Patients undergoing reconstructive Surgery with free radial forearm flap, anterolateral thigh flap, medial sural artery perforator flap- Descriptive longitudinal study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Preoperative and post operative speech,tongue movement,and swallowing reflex
研究概览
简要总结
Tongue cancer -most common intraoral malignancy.In most of these cases, radical ablation & immediate surgical reconstruction of tongue defects are performed .While carrying out the reconstruction, it is necessary to rebuild the function & appearance of the tongue. It is also important to reduce the damage of the donor site on both function & appearance.Radical surgical therapy often diminishes oral functions & subsequently speech, swallowing, chewing, oral rehabilitation, nutrition, & appearance being issues of particular importance.The impairment in the functional outcome of the tongue is due to loss of bulk, musculature, damage of innervations, post-operative and post radiotherapeutic fibrosis.Surgeons have endeavored to overcome these unfavorable outcomes with a steadily improving understanding of the concepts underpinning microvascular free flaps.This study will help us to analyze the functional outcome of each flap & its versatility for the reconstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with histopathology report of squamous cell carcinoma of the tongue Patients who requires free flaps for reconstruction.
排除标准
- •Patients with T1 Carcinoma of the tongue, as they will need primary closure after tumor resection.
- •Patients with free flap failures that are not salvageable will be excluded.
- •Patients presenting with the recurrence will be excluded.
- •Patients who had received prior Radiation &/ Or Chemotherapy.
- •Pregnant patients.
结局指标
主要结局
Preoperative and post operative speech,tongue movement,and swallowing reflex
时间窗: Speech: Baseline reading Pre-operatively, then post-operatively at 1 weeks, 4 weeks, 12 weeks, 24 weeks. | Tongue movement: Baseline reading Pre-operatively, then post-operatively at 1 weeks, 4 weeks, 12 weeks, 24 weeks. | Swallowing reflex: Baseline reading Pre-operatively, then post-operatively at 1 weeks, 4 weeks, 12 weeks, 24 weeks.
次要结局
- Quality of life,wound healing,donor site(Quality of life at 4 weeks, 8 weeks, 12 weeks.)
研究者
Dr. Monal Karkar
Rural Dental College, PMT PIMS(DU)