KOREAN Enhanced RecOvery Strategy for Colorectal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 101
- 试验地点
- 3
- 主要终点
- Postoperative Outcome
研究概览
简要总结
This is a multi-centre study to take place in approximately 3 centers in Seoul, South Korea. The study will be carried out as a prospective, randomized, controlled, multicenter, clinical trial in patients undergoing colorectal surgery. The purpose of this study is to determine if an enhanced recovery strategy paying close attention to the type and amount of fluid given during the surgery with proper monitoring combined with a comprehensive perioperative pain management will have a better post-operative outcome compared to institutional standard of care (SOC), in patients undergoing surgery of the colon. One of the fluids used, Volulyte®, is an intravenous solution used to treat low blood volume. The Volulyte® solution being used in the study and the monitor used are approved by the Korean Food and Drug Administration
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective, open colorectal surgery including sigmoid resections, i.e. with an upper rectal anastomosis and with or without planned stoma. If the planned surgery is a combined procedure, the associated procedure should not add more than 1 hour to the surgery time of the primary colorectal surgical procedure alone.
- •Both genders; age ≥ 45 years and ≤ 80 years.
- •ASA Grades I-III
- •Voluntary participation and signing the informed consent form
排除标准
- •Fluid overload (hyperhydration), especially in cases of pulmonary edema and congestive heart failure, or patients with severe cardiovascular disorders (New York Heart Association, NYHA III-IV)
- •Patients with significant cardiac arrhythmias or depending on pacemaker
- •Patients with impaired liver and/or kidney functions (ALT more than 2 times the normal upper limit and/or Serum Creatinine (SCr) more than 2 times the normal upper limit)
- •Renal failure with oliguria or anuria not related to hypovolemia
- •Patients receiving dialysis treatment
- •Patients with non-resectable malignancies
- •Patients who are non-cooperative or non-communicable
- •Patients with significant preoperative coagulation abnormalities
- •Patients receiving treatment with opioids for significant chronic pain
- •Patients in need of organ transplantation
- •Intracranial hemorrhage
- •Severe hypernatremia (Na+ > 155 mmol/l) or severe hyperchloremia (Cl- > 125 mmol/l)
- •Known hypersensitivity to hydroxyethyl starches
- •Participation in a clinical trial of an investigational drug or device within 30 days before study screening visit or is scheduled to receive an investigational product while participating in this study
- •Patients with evidenced bowel obstruction symptoms.
- •Contraindication to epidural anesthesia
- •Known pregnancy and lactation
研究组 & 干预措施
Standard of Care (SOC)
Intraoperative fluid management includes Volulyte® (6% hydroxyethyl starch {HES} 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg. Intraoperative anesthesia and postoperative analgesia will follow the established practice of the individual institution.
干预措施: Volulyte® (6% HES 130/0.4 in balanced solution) (Drug)
Enhanced Recovery Strategy (ERS) group
GDFT regimen using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg. Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.
干预措施: Combined epidural-general anesthesia (CEGA) (Other)
Enhanced Recovery Strategy (ERS) group
GDFT regimen using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg. Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.
干预措施: Volulyte® (6% HES 130/0.4 in balanced solution) (Drug)
Enhanced Recovery Strategy (ERS) group
GDFT regimen using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg. Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.
干预措施: Patient-Controlled Epidural Analgesia (PCEA) (Other)
结局指标
主要结局
Postoperative Outcome
时间窗: From Day 1 after surgery and duration of hospital stay (approximately 6 days after surgery)
Postoperative outcome is defined as the number of patients who develop at least one postoperative complication during their hospital stay
次要结局
- Number of postoperative complications per group(Participants will be followed for the duration of hospital stay (approximately 6 days after surgery), and until 4 weeks from day of surgery)
- Change in Postoperative pain(1h, 2 h, 6 h, 24 h post-surgery, and post-operative days 1 through 5, and at discharge)
- change in incidence of nausea and vomiting(1h, 2 h, 24 h post-surgery, and post-operative days 2 through 5, and at discharge from the hospital (approximately 6 days after surgery))
- Postoperative outcome for each patient at postoperative day (POD) 30(From Hospital Discharge (approximately 6 days after surgery), up to 4 weeks after day of surgery)
- Time to "clinically fit for discharge from hospital"(From 4 days after surgery to Hospital discharge (approximately 6 days after surgery))