Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Recurrent bleeding within 30 days after initial endoscopy defined as -
研究概览
简要总结
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.
详细描述
We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.
When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.
Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.
We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.
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
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
- •age 15 - 90 years
- •Written consent available
排除标准
- •ulcer bleeding not controlled in first endoscopy
- •Bleeding from malignant ulcer or tumor
- •Bleeding from Dieulafoy lesion/ angiodysplasia
- •Bleeding from injection sclerotherapy ulcer
- •Patient with ASA category 5
结局指标
主要结局
Recurrent bleeding within 30 days after initial endoscopy defined as -
Clinical criteria (anyone of the below)
1. Haemetmesis or fresh blood from Ryles tube
2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
AND Endoscopic criteria of Forrest I a, b or II a, b
次要结局
- 1. The rate of surgery
- 2. Mortality
- 3. Length of Hospital stay
- 4. Transfusion