Outcome of Perioperative Immune Enhancing Nutrition in Patients Undergoing Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Wound healing
研究概览
简要总结
The aim of this study is to evaluate the outcome of perioperative immune-nutrition with glutamine, arginine and fish oil in patients undergoing radical cystectomy as regards to enhancement of healing, increasing immunity and improving overall health status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CT showing bladder mass with radiological staging of T2 or T
- •Patients pathologically proven to have cancer bladder.
- •Patients undergoing radical cystectomy with ileal conduit.
- •The American Society of Anesthesiologists Physical Status classification system (ASA PS) of 1, 2 or 3.
排除标准
- •Coagulopathy.
- •Distant metastasis.
- •Body mass index less than 18.
- •Relevant food allergies.
- •Severe renal and hepatic insufficiency.
研究组 & 干预措施
immune enhancing nutrition protocol group
patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively.
干预措施: Neo-mune powder (otsuka pharmaceutical) (Dietary Supplement)
immune enhancing nutrition protocol group
patients who are enrolled in pre and post operative routine preparation for surgery protocol plus immune enhancing nutrition administration pre and post operatively.
干预措施: Dipeptiven solution (Fresenius Kabi pharmaceutical) (Drug)
结局指标
主要结局
Wound healing
时间窗: 30 days
The number of properly healed wounds. wound healing will be assessed by Pressure Ulcer Scale for Healing (PUSH) tool. this tool give every wound a score depending on surface area, exudate amount and tissue type. the scoring system ranging from 0 to 17 in which "0" represents completely healed wound and "17" represents the least healed wound. Surgical wounds are acute wounds that closure expected timeframe is about 4 weeks.
infectious complications
时间窗: 30 days
infection rate will be assessed by need for intervention or prescription of non-prophylactic antibiotics or presence of systemic inflammatory response syndrome (SIRS).
Postoperative complications
时间窗: 30 days
The number of postoperative complications, either infectious or non-infectious. Postoperative complications will be assessed and classified according to modified Clavien-Dindo classification. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) in which grade I represents the least severe complications and grade V represents the most severe complications.
次要结局
- Length of hospital stay(30 days)
- Length of ICU stay(30 days)
研究者
Ammar Fathi Mohamed AlOrabi
Ammar Fathi Mohamed AlOrabi
Menoufia University