A Simple Oral Nutrition Protocol Reduces Length of Stay in Patients With Regular Radical Cystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- the Postoperative Length of Stay
研究概览
简要总结
After radical cystectomy, postoperative ileus (POI) is a common complication resulting in a delayed oral nutritional intake with prolonged recovery and hospital stay. However, it is questionable if nutritional support by routine use of parenteral nutrition (PN) is justifiable.
A non-randomized before-after trial was conducted. Patients treated with an elective regular radical cystectomy and without preoperative contra-indications for enteral nutrition were eligible. In the control group, PN was initiated immediately after the procedure and continued until resumption of diet. In the interventional group, an ONP was implemented. PN could be initiated if oral intake was still insufficient after five days. The primary end point was the postoperative length of stay.
详细描述
Design
A prospective interventional non-randomized before-after trial was conducted. Eligible patients admitted from 01/02/2009 were consecutively assigned to the control group until the predefined sample size was reached. After enrollment and follow-up of control patients had been finished, all newly admitted eligible patients were consecutively assigned to the interventional group.
In addition to the before-after study, a sample of eligible patients was collected from March 2011 to March 2013 (follow-up group) to examine the post-study impact of the ONP.
Patients
All adult patients admitted to the 48-bed urological ward in the 1850 bed University Hospitals Leuven and treated with elective and regular RC, whether or not for underlying cancer, were eligible for inclusion. Three different diversions are performed: an ileal conduit, an orthothopic neobladder (N-pouch)12 or a continent cutaneous diversion. The surgical procedure was considered regular if the patient returned after the procedure to the urological ward and was not transferred to the intensive care unit. If the latter was deemed necessary by the treating surgeon, the patient would be subjected to the intensive care nutrition protocol. Therefore, only regular RC patients were included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •regular radical cystectomy
排除标准
- •preoperative contra-indications for enteral nutrition (EN): intestinal obstruction, malabsorption, multiple high-output fistula and intestinal ischemia
结局指标
主要结局
the Postoperative Length of Stay
时间窗: one month after surgery
The primary outcome measure was the interval from surgery to discharge. Discharge means that the patient returns to his home.
次要结局
- Number of Administered PN(30 days postoperative)
- Patients With One or More Postoperative Complication.(30 days postoperative)
- The Type of Postoperative Complications.(30 days postoperative)
- Severity Grade of Postoperative Complications.(30 days postoperative)
- Successful Implementation Rate of the ONP in the Experimental Group(30 days postoperative)
- The Number of Postoperative Complications Per Patient.(30 days postoperative)
- The Time to Resumption of Full Diet.(30 days postoperative)
- Patients With a Catheter Related Bloodstream Infection(30 days postoperative)