Role of preoperative nutritional intervention in improving surgical outcome in patients with oral squamous cell carcinoma A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- To assess the impact of preoperative nutritional intervention on the incidence of surgical site infection in operated patients of oral squamous cell carcinoma using the Southampton Wound Score as compared to patients following standard dietary practice in control group
研究概览
简要总结
Head and neck cancers are on a rising trend both in India and globally. Despite modern advancements in treatment modalities, morbidity and mortality of oral cancer patients are still high. Role of nutrition in health is common knowledge, yet it is underrated and underutilised in hospital setups mostly due to ignorance of both patients and doctors alike. Prevalence of malnutrition in Indian population is high which is further compounded in patients with oral squamous cell carcinoma due to poor oral intake. Poor preoperative nutritional status negatively impact surgical outcome by delayed wound healing and increase risk of surgical site infection and complications. This study can help in improved counselling of oral squamous cell carcinoma patients preoperatively regarding the significance of simple, easily available, culturally appropriate nutritional intervention that can improve surgical outcome and overall survival, and move a step towards implementing the same in daily practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants older than 18 years of age with oral squamous cell carcinoma Participants giving informed and written consent to take part in the study Patient should be able to eat food by mouth Patient should have functional gastrointestinal tract Patient should be undergoing surgery for oral squamous cell carcinoma for the first time Patient BMI should be between 18.5 to 25.5.
排除标准
- •Patients requiring nasogastric tube or feeding jejunostomy or parenteral nutrition Patients who received NACT before surgery Patients with preoperative HbA1c more than 7.850 percentage or postoperative HbA1c more than 6.650 percentage, preoperative fasting blood sugar more than 130.50mg per dL or postoperative fasting blood sugar more than 148.5mg per dL Patients diagnosed with chronic kidney disease, nephrotic syndrome Patients diagnosed with chronic liver disease Patients diagnosed with any autoimmune disorders Patient taking high dose corticosteroids for any condition at a dose more than 20mg Prednisolone or equivalent for more than 2 weeks within time interval of one month before date of surgery Patients with urine protein 1 plus Patients with lactose intolerance.
结局指标
主要结局
To assess the impact of preoperative nutritional intervention on the incidence of surgical site infection in operated patients of oral squamous cell carcinoma using the Southampton Wound Score as compared to patients following standard dietary practice in control group
时间窗: 2 months
次要结局
- To compare the difference in the Host Index in patients before and after receiving the nutritional intervention(To compare postoperative Host Index value of patients in intervention group and the control group)
研究者
Dr Anston Gerard Angelo
AIIMS New Delhi