Perioperative Supplementation With Immunonutrition and Its Impact on Surgical Outcome and Pain in Oral Cavity or Mandibular Tumours
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- The incidence of wound infection
研究概览
简要总结
The aim of this study was to investigate the effect of adding omega 3 and dipeptiven to standard feeding in head and neck patients who will undergo oral cavity tumour resection or mandibular tumour resection (immunonutrrition mixture) on wound infection, fistula formation and length of hospital stay ,total dose of intraoperative and postoperative opioids (opioid consumption and pain incidence ,mortality and other postoperative complications as urinary tract infection (UTI) and pneumonia.
详细描述
Enhanced Recovery after Surgery (ERAS). A series of components that combine to minimize stress and to facilitate the return of function have been described: these include preoperative preparation and medication, fluid balance, anesthesia and postoperative analgesia, pre- and postoperative nutrition, and mobilization.
Nutrition therapy is the provision of nutrition or nutrients either orally (regular diet, therapeutic diet, e.g. fortified food, oral nutritional supplements) or via enteral nutrition (EN) or parenteral nutrition (PN) to prevent or treat malnutrition.
Head and neck cancer surgery usually means surgery to treat cancer of the mouth, throat or larynx . The surgery is complicated and people often experience problems such as wound infections and wound breakdown, as well as infections such as pneumonia.
The use of a nutritional supplement enriched with Omega 3 fatty acids is associated with a greater preoperative weight loss, reduced postoperative pain and decreased postoperative levels of C reactive protein in patients undergoing Roux-en-Y gastric bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I or II .
- •Patient undergoing mandibular or oral cavity tumour resection.
- •Body mass index (BMI) between 18.5-24.
- •Patient with serum albumen above 3 gm.
- •Patient with written valid consent
排除标准
- •Patient refusal and uncooperative patients.
- •Patient ASA III or IV.
- •Age more than 60 or less than
- •Serum albumen less than
- •Pre-existing severe malnourishment.
- •Allergy to test drugs.
- •Patients on tranquilizers, hypnotics, sedatives and other psychotropic patient on steroids and NSAID.
结局指标
主要结局
The incidence of wound infection
时间窗: 28 days after intervention
Evidence of redness and tenderness of surgical wound with discharge of pus was defined as a wound infection.
次要结局
- The incidence of mortality(28 days after intervention)
- Fistula formation(28 days after intervention)
- Length of hospital stay(28 days after intervention)
- Total dose of intraoperative opioids(Intraoperative)
- Degree of pain(12 hours postoperative)
- Total dose of postoperative opioids(12 hours postoperative)
- The incidence of complications(12 hours postoperative)
研究者
Samar Saed Ramadan
Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Cairo University, Cairo , Egypt.
Cairo University