Early Oral Feeding Versus Traditional Delayed Oral Feeding Post-perforated Peptic Ulcer Repair: A Comparative Study in Egyptian Tertiary Health Care Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- number of days of hospital stay
研究概览
简要总结
This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population & Sample size :(
详细描述
Study Design:
This study is a single-center, prospective, parallel arm, randomized controlled trial. Patients will be randomly assigned in 1:1 ratio to receive either delayed oral feeding or early oral feeding.
Methods:
Patients will be randomly assigned into two groups. Group A patients followed an early oral feeding protocol(12 hours), and Group B received delayed oral feeding (72 hours).
Outcome parameter :
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
- Single (Participant)
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
- •- All consecutive patients, of age 18 years and above, who were
- •presented to the emergency surgical team and were diagnosed with perforated duodenal ulcer by surgicalteam, were recruited and assessed for eligibility.
排除标准
- •• Preoperative refractory septic shock on admission.
- •Delayed presentation more than 24 hours.
- •The presence of neuropsychiatric disease, pregnant and lactating women.
- •Predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV.
- •American society of anesthesiologists grade iii/iv, or had an alternative perioperative diagnosis.
- •Intraoperatively, after randomization, patients were excluded based on the following criteria: perforated duodenal ulcer ≥20 mm, consistent with malignant ulcers.
结局指标
主要结局
number of days of hospital stay
时间窗: Up to 10 days
number of days of hospital stay
days needed for frist Bowel motion
时间窗: 7 days
number of days before frist bowel motion
次要结局
- incidence of Ryle reinsertion(7 days)
- number of Readmission cases(30 days)
- incidence of Post operative repair leak(30 days)
- severity of operative pain measured by Visual Analogue Scale (VAS)(7 days)
- incidence of Surgical site infection(30 days)
- incidence of Pulmonary complications(30 days)
- INCIDENCE OF postoperative nausea and vomiting (PONAV)(7 days)
研究者
Mohammed Elshwadfy Nageeb
lecturer of general surgery
Cairo University