Advantage of a Fast-recovery Protocol for Minimally Invasive Kidney Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Length of hospital stay
研究概览
简要总结
Shorten the time spent in the hospital (hospitalization duration) by optimizing the pre, per and postoperative care is of major medical and economic importance.
Minimally invasive surgery allows a faster recovery than open surgery. However, we need to ensure an early and secure return to normality in order to discharge patients safely from the hospital.
Clinical and biological parameters need to be controlled post-surgery.
This work is going to evaluate the efficacity of a fast - recovery program with incoming patients receiving minimally invasive surgery (laparoscopic or robotic) of partial and total nephrectomy.
The implementation of a medical and surgical fast-recovery program could
- Lower the average duration of stay in hospital (at least by 1 day) with no increase of morbidity
- Insure the absence of complications after 6 months home
详细描述
Prospective study of a fast recovery program evaluating the impact on the hospitalization length and the incidence of re-hospitalization for complications for 60 patients undergoing a minimally invasive nephrectomy.
The cohort will beneficiate of an extra preoperative information about the enhanced recovery after surgery program, they will benefit from a strategie of low morphine consumption during the per end post operative phase, they should need no bladder or abdominal drainage, they're encourage to eat and drink a few hours after surgery, the intravenous fluid is interrupted as early as possible, and the patients are encourage to sit, stand up and get dressed as soon as they are capable.
A form completed by the patient registers their every day capabilities to eat, drink, move, and their limitations due to pain, dizziness, and nausea. Their bowel and urine transit are also registered. This form is complete until discharge from the hospital.
Their laboratory test is monitored to identify kidney insufficiency or anemia and compared with the preoperative laboratory tests.
The hospital discharge is allowed after medical and surgical criteria are met in both groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient score from the American Society of Anesthesiologist (ASA) I, II or III stable
- •Patients undergoing minimally invasive surgery (laparoscopic or robotic) partial or total unilateral nephrectomies for tumoral < pT2 stage (7 cm) with no tumor spread of the retro-peritoneal tissue, vascular or urinary tract.
- •Surgery must be performed by a laparoscopic and robotic-assisted surgeon, operator must be trained using these techniques
排除标准
- •Patient score from the American Society of Anesthesiologist (ASA) III unstable, IV and V
- •Patients with renal insufficiency defined by clearance < 60 ml/min/1,73m2 (CKD-EPI)
- •Patients with high embolic risk under long-term anti-coagulation medication
- •Patients with congenital hemostatic deficit or antiplatelet treatment
- •Patients with long term corticosteroids treatments
- •History of kidney surgery or congenital unique kidney
- •History of multiple abdominal surgery creating a hostile surgical environment
- •intestinal chronic disease or chronic pain syndrome
- •Psychiatric disorder, cognitive impairment reducing the ability to understand the discharge instructions
- •Pregnant or breast-feeding women
- •Patients with no social security covers
结局指标
主要结局
Length of hospital stay
时间窗: at 1 month
次要结局
- Preoperative and postoperative Creatinine and Clearance of creatinine Delta by the CKD-EPI formula(Baseline, at 24 hours, at 1 week and at 6 months)
- Hospital readmission rate at 1 month post surgery(at 1 month)
- Average Satisfaction of hospital stay and discharge on a satisfaction numerical scale(at 1 month post surgery)
- Neuropathic pain by Douleur Neuropathique 4 (DN4) questionnaire.(3 and 6 months post surgery)
- Postoperative antalgic consumption in Enhanced recovery after surgery patients(through the hospitalization, up to 5 days post surgery and long term, average of 6 months post surgery)