Impact of Enhanced Recovery After Surgery (ERAS) Pathway on Outcomes in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The time required for the PADS score to meet the standard.
研究概览
简要总结
Prostate cancer ranks second among all malignances in men and has become a significant threat to men's health. Robot-assisted laparoscopic radical prostatectomy (RARP) has become a standard treatment for prostate cancer. How to improve recovery following RARP surgery is worth investigating. The enhanced recovery after surgery (ERAS) pathway involves a series of evidence-based procedures. It is aimed to reduce the systemic stress response to surgery and shorten the length of hospital stay. This randomized trial aims to investigate the impact of Enhanced Recovery After Surgery (ERAS) Pathway on early outcomes after RARP surgery.
详细描述
Prostate cancer ranks second among all malignancies in men and has become a significant threat to men's health. Surgical resection is the main treatment for patients with early and locally advanced prostate cancer. With the progress of technology, robot-assisted laparoscopic radical prostatectomy (RARP) is gradually accepted by surgeons and become the first line treatment for prostate cancer. How to improve recovery after RARP surgery is worth investigating.
The concept of enhanced recovery after surgery (ERAS) was first reported by Dr. Kehlet. The ERAS pathway involves a series of evidence-based managements to accelerate patients' rehabilitation, including selective bowel preparation, nutritional therapy, fluid management, multimodal analgesia, early mobilization, etc. It has been applied to many patient populations including those undergoing gastrointestinal surgery, cardiothoracic surgery, and urological surgery. Previous studies showed that practicing ERAS in patients undergoing laparoscopic prostate surgery shortened the time to flatus and defecate and the length of hospital stay. Specifically, prehabilitation including aerobic exercise and pelvic floor training may be beneficial and improve physical wellbeing in patients undergoing prostatectomy. However, little is known regarding the effects of ERAS in patients undergoing RARP surgery.
The purpose of this randomized controlled trial is to investigate the impact of ERAS management, including prehabilitation, on early outcomes in patients undergoing RARP surgery.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Aged 60 years or over but below 90 years.
- •Scheduled to undergo robot-assisted laparoscopic radical prostatectomy (RARP) for prostate cancer.
- •Agree to participate in this study and give written informed consent.
排除标准
- •Scheduled to undergo combined surgery, including RARP combined with pelvic lymph node dissection or other procedures.
- •American Society of Anesthesiologists (ASA) physical classification ≥IV.
- •Inability to receive preoperative aerobic exercise because of severe cardiovascular disease, motor system diseases (arthritis, lumbar vertebrae disease), or central nervous system diseases (epilepsy, parkinsonism).
- •Inability to communicate in the preoperative period because of profound dementia, deafness, or language barriers.
- •History of schizophrenia, anxiety or depressive disorders, or other mental disorders.
结局指标
主要结局
The time required for the PADS score to meet the standard.
时间窗: Up to 30 days after surgery.
The time required to achieve a post-anesthesia discharge score (PADS) of 9 or above after surgery.
次要结局
- Total hospitalization cost within 30 days after surgery(Up to 30 days after surgery)
- Incidence of postoperative complications within 30 days after surgery(Up to 30 days after surgery)
- Perioperative anxiety score(On the day before surgery and at day 1 after surgery.)
- Incidence of readmission within 30 days after surgery(Up to 30 days after surgery)
- Perioperative depression score(On the day before surgery and at day 1 after surgery.)
- Pain score within 3 days after surgery(Up to 3 days after surgery)
- Overall survival within 90 days after surgery(Up to 90 days after surgery)
研究者
Dong-Xin Wang
Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital