Enhanced Recovery After Surgery(ERAS) Protocols Versus Conventional Care Protocols Following Emergency Laparotomy: A Randomized Double Blinded Study
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 2.Morbidity and mortality during the first 30 days after surgery
研究概览
简要总结
This prospective double blinded study is being undertaken to compare the clinical outcomes of application of ERAS protocols and conventional care protocols on patients undergoing Emergency Laparotomies for Acute Intestinal perforations and Acute Intestinal Obstructions. Our aim is toinvestigate the feasibility and beneficial effects of Enhanced recovery aftersurgery in the setting of emergency laparotomy. The primary outcomes are tocompare the surgical outcome in terms of post operativecomplications,mortality, length of stay and re admission rate in patients withacute abdomen undergoing emergency laparotomy with ERAS protocols and those with conventional post operativecare. The secondary objectives are toevaluate the applicability,safety and effectiveness of ERAS in emergencysurgeries and tostandardise and optimise peri operative care in order to reduce surgicaltrauma,peri operative physiological stress and organ dysfunction. The patients will be randomly divided intotwo groups using a computer generated allocation software(Random AllocationSoftware)and allocation concealment will be done by a sealed envelope toprevent prior knowledge of treatment assignment. The numbers will be assignedin strict chronological sequence and study participants will be entered in thesequence. Each study patient will be allocated a unique randomization number onsuccessful completion of screening, to be assigned to receive either one of thegroups. The patients will be assessed postoperatively for complications, mortality,length of stay and readmission rate.The patients will be followed up till 30 days post operatively. The primary endpoints will be thelength of hospital stay and morbidity and mortality during the first 30 daysafter surgery. Morbidities will include superficialand organ/space-type SSIs, postoperative ileus, pulmonary complicationsincluding atelectasis and pleuraleffusion and postoperative bleeding. The secondary endpoints will be the time elapsed until theresumption of oral feeding, the need for nasogastric tube reinsertion, the needfor extra analgesics, the readmission rate, and the reoperation rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 19.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age >18 years with pre operatively diagnosed perforation peritonitis and acute intestinal obstruction planned for emergency laparotomies.
- •2.ASA grade Ie to IIIe 3.Hemodynamically stable 4.Patients giving Informed consent for the study.
排除标准
- •1.Pregnant patients.
- •2.Patients on chronic steroids.
- •3.Spontaneously sealed-off perforated ulcers that were diagnosed either preoperatively or during surgery and that did not require surgical repair.
- •4.Malignant ulcers confirmed by histopathological examination if biopsied for a high index of suspicion for malignancy.
- •5.Laparoscopic surgeries.
- •6.Acute abdominal trauma surgeries.
结局指标
主要结局
2.Morbidity and mortality during the first 30 days after surgery
时间窗: 1.The length of hospital stay. | 2.Morbidity and mortality during the first 30 days after surgery
1.The length of hospital stay.
时间窗: 1.The length of hospital stay. | 2.Morbidity and mortality during the first 30 days after surgery
次要结局
- The time elapsed until the resumption of oral feeding, the need for nasogastric tube reinsertion, the need for extra analgesics, the readmission rate, and the reoperation rate.(30 days)