The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 4
- 主要终点
- Infectious complication after cystectomy
研究概览
简要总结
The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy.
As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN.
This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.
详细描述
Despite standardized surgical technique and the development of new perioperative care protocols, cystectomy morbidity remains a serious challenge for urologists. Most common postoperative complications, such as infections, often lead to longer length of stay and worse survival. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. Immunonutrition (IN), containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids, aims to improve the nutritional status, immunological function and clinical outcome of surgical patients. Meta-analyses have demonstrated that preoperative IN reduces complications and length of hospital stay after major bowel surgery. Evidence-based data on preoperative oral IN support for cystectomy patients are lacking, which does not allow this treatment to be widely accepted, recommended, or reimbursed by health insurances in most European countries. Uncertainties also remain about the exact mechanism by which IN modulates the host immune response.
Complication rates after cystectomy range from 40-75%. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. To date, and in the last 20 years, no single intervention has allowed for a significant reduction in morbidity after cystectomy, which remains one of the highest in surgery. The present adequately powered multicenter RCT has the potential of changing current practice by recommending preoperative IN before cystectomy in case of positive results. If the present RCT demonstrates a benefit in administrating IN prior to cystectomy, urological guidelines will be modified accordingly to this new evidence. IN will then be recommended before cystectomy for the patient's benefit. The investigators truly believe that the proposed study is of high clinical importance with potential impact on perioperative urology guidelines.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing open cystectomy (for all reasons)
- •Age ≥18 years
- •Ability and willingness to provide informed consent documented by signature
排除标准
- •Contraindications to IN, e.g. known hypersensitivity or allergy to lactose, fish oil or soy lecithin
- •Severe diarrhoea requiring medical attention
- •Current treatment with any immunosuppressive drug
- •In standard practice, pregnant or lactating women are systematically rejected by the surgeon for this surgical procedure. Furthermore, during the pre-surgical anaesthesia consultation, the eligibility of each patient for anaesthesia will be assessed according to the usual criteria and recommendations of the anaesthesia service of the CHUV
- •Other clinically significant concomitant disease affecting immunity (e.g., severe renal failure, HIV, SLE, transplant recipient, ...)
- •Inability to follow the procedures of the study, e.g. due psychological disorders, dementia, etc.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Previous enrolment into the current study
- •Use of IN independently of the study
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •Emergency procedure (less than 7 days between screening and surgery)
研究组 & 干预措施
Immunonutrition
Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition
干预措施: Immunonutrition (Drug)
结局指标
主要结局
Infectious complication after cystectomy
时间窗: 30-days afetr surgery
Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).
次要结局
- Mortality rate(30 and 90 days after surgery)
- Comprehensive Complication Index (CCI)(30 and 90 days after surgery)
- Complication-free survival rate(90-days after surgery)
- Treatment compliance rate(Between Day -30 and Day -10 and at preoperative admission after intake of the allocated nutrition (Day -1))
研究者
Ilaria Lucca
MD, Principal Investigator
Centre Hospitalier Universitaire Vaudois