Safety and Efficacy of Enhanced Recovery After Surgery (ERAS) in Patients Undergoing Emergency Laparotomy: A Single Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- postoperative recovery time
研究概览
简要总结
The goal of this clinical trial is to test the safety and effectiveness of the ERAS protocols compared to a conventional care protocols in patients who received emergency laparotomy. The main question it aims to answer are:
• Can the ERAS protocols be used safely and effectively in patients undergoing emergency laparotomy? Participants will be randomised into the ERAS group and the conventional group and will be given the ERAS protocols and the conventional protocols in the perioperative period.
Researchers will compare the ERAS group with the conventional group to see if the ERAS programme is effective.
详细描述
Since Kehlet first proposed enhanced recovery after surgery (ERAS) protocols in the 1990s, researchers have been widely adopted. Preoperative counseling, standardized anesthesia management protocols, more optimal postoperative analgesic regimens, restriction of intubation and catheterization, early postoperative mobilization, and early oral intake of food are all part of ERAS programs. These programs began in colorectal surgery and have now been expanded to other surgical specialties. Several studies have shown that patients benefit from ERAS programs, including reduced pain, faster return to bowel function, shorter hospital stays, and lower health care costs. However, investigators found that ERAS programs are rarely used for emergency surgery.
Emergency surgery is the treatment of choice for acute abdominal conditions such as traumatic liver rupture, traumatic splenic rupture, and complete bowel obstruction. Nevertheless, investigators found that most clinical studies of ERAS excluded patients who underwent emergency surgery. This is because most researchers probably believe that emergency surgery does not allow enough time for ERAS-related preoperative preparation. In fact, some ERAS programs can be used for emergency surgery, such as the anesthetic modality of combined anesthesia, postoperative multimodal analgesia, earlier postoperative oral feeding and ambulation, and earlier removal of invasive catheters. However, few studies have focused on the use of ERAS in emergency surgery.
The present study is a randomized controlled trial evaluating the safety and efficacy of an ERAS program in emergency abdominal surgery. Investigators hypothesized that an ERAS program could be implemented into emergency surgery and reduce postoperative recovery time without increasing the complication rate and readmission rate (<30 days).
The standard operating procedures for the study are as follows:
- Participants will be randomised into the ERAS group and the conventional group.
- Preoperative care: A number of preoperative protocols were similar in both groups, including (1) surgical risk assessment; (2) preoperative placement of a nasogastric tube (NG); (3) preoperative administration of crystalloid fluids to replenish blood volume; (4) empiric antibiotics and acid-reducing therapy administered intravenously; and (5) intravenous analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages 18-70,
- •Patients who completed the preoperative examination and preoperative diagnosis within 4 hours after admission for acute abdomen diseases,
- •Required emergency surgery within 6 hours from surgeon encounter.
排除标准
- •Patients who refused to be enrolled in this study;
- •Patients with any psychiatric or neurological disorders;
- •Pseptic shock at admission;
- •Duration of symptoms more than five days;
- •Patients with contraindications to the placement of lumbar epidural catheters, such as coagulation disorders, severe sepsis, etc.;
- •Presence of preoperative factors affecting wound healing (e.g. long-term steroid use);
- •Patients with extra-abdominal injuries or terminal malignancy, or patients requiring damage control surgery;
- •Patients found intraoperatively to require any procedure other than splenectomy, partial hepatectomy or liver repair, bowel resection and anastomosis, laparoscopic cholecystectomy and appendectomy, and gastrointestinal perforation repair.
结局指标
主要结局
postoperative recovery time
时间窗: From enrollment to the end of treatment at 2 weeks
Postoperative recovery time that meets the relevant definitions in this study
次要结局
- The time to tolerate soft food after surgery(From enrollment to the end of treatment at 2 weeks)
- The time of first postoperative flatus(From enrollment to the end of treatment at 2 weeks)
- The rate of readmission (in 30 days)(From enrollment to the end of treatment at 2 weeks)
- the rate of postoperative complications(From enrollment to the end of treatment at 2 weeks)
- The time to tolerate semi-fluid diet after surgery(From enrollment to the end of treatment at 2 weeks)
研究者
Jianing Lu
Director
Tianjin Medical University