Comparison of Enhanced Recovery Protocol After Surgery Versus Conventional Care in Emergency Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Surgical Site Infection
研究概览
简要总结
This study aims to compare an Enhanced Recovery After Surgery (ERAS) protocol with conventional postoperative care in adults undergoing emergency laparotomy for intestinal obstruction or intestinal perforation.
The main question this study aims to answer is:
• Does the ERAS protocol reduce surgical site infections compared with conventional care after emergency laparotomy?
Researchers will also compare other recovery outcomes between the two groups, including length of hospital stay, occurrence of paralytic ileus (temporary loss of bowel function), time to first bowel movement, and time to start taking fluids by mouth after surgery.
A total of 102 participants will be enrolled and randomly assigned to one of two groups. One group will receive postoperative care according to the ERAS protocol, while the other group will receive conventional postoperative care. All participants will undergo emergency laparotomy using standard surgical and anesthetic techniques.
Participants will:
- Undergo emergency laparotomy for intestinal obstruction or intestinal perforation.
- Receive either ERAS-based postoperative care or conventional postoperative care.
- Be monitored during their hospital stay for recovery and postoperative complications.
- Be assessed for bowel function recovery, ability to tolerate oral fluids, and length of hospital stay.
- Be followed for 30 days after surgery to determine whether a surgical site infection develops.
The researchers hypothesize that patients managed with the ERAS protocol will have a lower frequency of surgical site infections and improved postoperative recovery compared with those receiving conventional care.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute intestinal obstruction or intestinal perforation
- •planned for emergency laparotomy
排除标准
- •Pregnant women
- •Patients on chronic steroids
- •Chronic obstructive pulmonary disease
- •Malignant ulcers confirmed by histopathological examination
- •laparoscopic surgeries
- •Acute abdominal trauma
- •Patients who require postoperative intensive care unit (ICU) care
研究组 & 干预措施
ERAS Protocol Group
Participants undergoing emergency laparotomy will receive postoperative care according to the Enhanced Recovery After Surgery (ERAS) protocol.
干预措施: Enhanced Recovery After Surgery (Procedure)
Conventional Care Group
Participants undergoing emergency laparotomy will receive standard postoperative care as routinely practiced in the surgical unit.
干预措施: Conventional Postoperative Care (Procedure)
结局指标
主要结局
Surgical Site Infection
时间窗: From enrollment within 30 days postoperatively
Frequency of surgical site infection (superficial and deep) occurring within 30 days after emergency laparotomy will be assessed and compared between the Enhanced Recovery After Surgery (ERAS) group and the conventional care group. Surgical site infection will be defined and classified according to standard surgical infection criteria as specified in the study protocol
次要结局
未报告次要终点
研究者
Sarfraz Hussain
Principal Investigator
Recep Tayyip Erdogan Hospital Pakistan - Muzaffargarh