Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Primary Study Endpoint
研究概览
简要总结
Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.
详细描述
This study will randomize patients with first episode of acute diverticulitis of the colon with extraluminal air and/or abscess as defined by CT scan following nonoperative management (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •older than or equal to 18
- •history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol
- •the diagnosis confirmed by colonoscopy
- •Signed informed consent
排除标准
- •Prior episode of diverticulitis
- •Right sided diverticulitis
- •Failure of recovery from first episode, defined as recurrence within one month.
- •Cancer found at the site on screening colonoscopy
- •Comorbidities prohibiting surgery (as measured by colorectal POSSUM score)
- •Immunosuppressed patients
- •Hinchey I, III, or IV (diverticulitis with peritonitis and/or free air under the diaphragm)
- •Patients who are unable to sign the informed consent
研究组 & 干预措施
Observational
The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
Surgery
The surgery group will be offered colon resection.
干预措施: Colon resection (Procedure)
结局指标
主要结局
Primary Study Endpoint
时间窗: Minimum of 1 year after enrollment
The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.
次要结局
- Recurrence and Treatment(2 years)
- Post Operative Complications(30 days)
- Measure Length of Hospital Stay for Surgery vs Non Surgery Patients(4 years)
- Mortality(4 years)
- Readmission(30 days)