The Feasibility of Fast-track Surgery for Perforated Peptic Ulcers. A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- The morbidity and mortality rate
研究概览
简要总结
The concept of "enhanced recovery after surgery" has become increasingly popular in elective abdominal surgeries. Yet, the role of this concept has not been described in emergency procedures. Therefore, this study aimed to investigate the feasibility of fast-track surgery in patients with perforated peptic ulcer.
详细描述
The study is designed as a randomized, controlled clinical study. The patients with a preoperative diagnosis of perforated peptic ulcer will be recruited for the study. Among those, the patients with a definitive diagnosis of perforated peptic ulcer confirmed by surgical exploration will be included.
The patients will be randomized according to their protocol number given automatically by the registration system of the hospital during admission. The patients who have an odd protocol number will have conventional surgical protocol, and those who have an even protocol number will have fast-track surgery protocol.
The conventional surgical protocol for perforated peptic ulcers is composed of regular general anesthesia, postoperative pain control by intravenous analgesics, removal of nasogastric tube by the end of 48th postoperative hour, initiation of oral intake after clinical signs of active bowel movement is observed. Fast-track surgery protocol, however, is composed of general anesthesia with short-acting agents and the use of regional anesthesia if possible, removal of nasogastric tube during recovery from anesthesia, aggressive pain control, initiation of oral intake by the end of 48th postoperative hour.
All of the patients will be scheduled for control gastroscopy in the end of six weeks after surgery.
Primary end-point is the morbidity and mortality rate. Secondary end-points are length of hospital stay, readmission rate, endoscopic findings in control gastroscopy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perforated peptic ulcer located in the stomach or the duodenum
排除标准
- •The patients who refuse to join the study or to sign the informed consent form
- •The patients who are unable to understand and sign the informed consent form
- •Age younger than 18
- •The patients with a possibility of having trouble in communicating with or reaching the investigators during the first 6 weeks after surgery
- •The patients who are considered as ASA class 4
- •Shock on admission
- •The patients who have serious negative factors for wound healing such as steroid usage, autoimmune diseases
- •Previous upper abdominal surgery
- •The patients who are found to have a pathology other than perforated peptic ulcer during surgical exploration
- •The patients who are found to have malignant ulcer during surgery or in postoperative period
- •Concomitant bleeding peptic ulcers
- •Peptic ulcer perforations with a diameter greater than 5 mm, which are not suitable for simple repair techniques
- •Multiple perforated peptic ulcers
结局指标
主要结局
The morbidity and mortality rate
时间窗: First 6 weeks after surgery
次要结局
- Length of hospital stay(An expected average of 5 days)
- Readmission rate(The period within the first 6 weeks after surgery)
- Endoscopic findings in control gastroscopy(At the end of 6 weeks after surgery)
研究者
Murat Gonenc
M.D.
Bakirkoy Dr. Sadi Konuk Research and Training Hospital