跳至主要内容
临床试验/NCT01047462
NCT01047462已完成不适用

Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial

University Hospital, Akershus2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
90 days complication rate

研究概览

简要总结

The purpose of this study is to determine whether laparoscopic lavage changes the rate of severe complications in patients with acute perforated diverticulitis who traditionally are treated with primary resection.

详细描述

Acute diverticulitis is a common disease in the western world. Perforation of the acute diverticulitis with peritonitis is a feared complication and standard treatment (primary sigmoid resection such as Hartmann's procedure) still has unsatisfactory results. Both mortality and morbidity are quite high. Several uncontrolled trials have reported a lower mortality and morbidity when acute perforated diverticulitis is treated with laparoscopic lavage instead of radical surgery. The investigators wish to conduct a randomized multicenter trial in Scandinavia in order to compare the rates of severe postoperative complications in acute perforated diverticulitis if treated by traditional primary sigmoid resection or by laparoscopic lavage. The investigators are planning to include all patients admitted to the participating hospitals with clinical and radiological findings of acute perforated diverticulitis.

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

入选标准

  • age over 18
  • clinical suspicion of perforated diverticulitis with indication for urgent surgery
  • CT scan with free air and findings suggesting diverticulitis
  • patient tolerates general anaesthesia
  • patients written consent

排除标准

  • pregnancy
  • bowel obstruction

结局指标

主要结局

90 days complication rate

时间窗: 90 days

次要结局

  • Quality of life(1 year)

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tom Oresland

Professor

University Hospital, Akershus

研究点 (2)

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