Prophylactic Elective Clipping of Colonic Diverticula in Patients Who Have Had Sustained Lower Gastrointestinal Haemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- The primary outcome will be episodes of recurrent bleeding requiring hospitalization.
研究概览
简要总结
Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may require hospitalization with blood transfusion and emergent intervention, with significant associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode will have subsequent episodes.
Diverticula form at weak points along the colon wall, where the vasa recta enter the circular muscle layer of the colon. Diverticular bleeding is attributed to thinning of the blood vessels as they cross over the dome of a diverticulum. Endoscopic clipping of actively bleeding colonic diverticula has been recognized as a safe and effective treatment for acute LGIB since the mid1990s. Patients selected would have had previous colonoscopy to exclude other causes of bleeding (e.g. angiodysplasia, colorectal cancer).
The investigators propose prophylactic elective endoscopic diverticular clipping in patients who have had at least 1 episode of acute LGIB requiring hospitalization. This would involve applying endoscopic clips to the base of every diverticula in a patient's colon, such that any bleeding source would effectively be excluded. The investigators would later reevaluate patients for colonoscopic appearance of diverticula to assess their diverticular disease.
The investigators hypothesize that patients undergoing endoscopic diverticular clipping will not have repeat episodes of bleeding.
详细描述
1.0 BACKGROUND AND HYPOTHESES
The investigators aim to prophylactically clip all colonic diverticula in patients who have experienced at least 1 episode of diverticular bleeding requiring hospitalization, but without definitive procedure (i.e., total colectomy or localization with embolization or clipping). The investigators' objective is to prevent future episodes of colonic bleeding from the diverticula, so as to avoid morbidity and possible mortality.
The investigators hypothesize that those patients undergoing secondary prophylaxis through diverticular clipping will experience no further episodes of diverticular bleeding.
2.0 OBJECTIVES AND PURPOSE
Diverticular bleeding is the most common cause of acute lower gastrointestinal bleeding (LGIB) in Western populations. Although self-limited in 85% of cases, some patients may require hospitalization with blood transfusion and emergent intervention, with significant associated morbidity and mortality. Up to 25% of patients with an initial bleeding episode will have subsequent episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients will be included if they have been hospitalized at least once with diverticular bleeding.
排除标准
- •Patients who had a definitive procedure to stop diverticular bleeding, including colectomy or angiography with embolization.
- •Patients who are considered too high risk for colonoscopy or bowel preparation. There will be no exclusion criteria based on age. Rather, patients will be individually evaluated and judged for frailty.
- •Patients on anticoagulant agents that may not be stopped for colonoscopy.
- •Patients without colonic diverticula
结局指标
主要结局
The primary outcome will be episodes of recurrent bleeding requiring hospitalization.
时间窗: 12 months
Postprocedure, patients will follow-up every 6 months either in Diverticular Disease clinic or via telephone checkup. These visits will ascertain whether patients have had recurrent bleeding episodes.
次要结局
未报告次要终点