ISRCTN82208287已完成不适用
Diverticulitis - laparoscopic lavage versus resection (Hartman procedure) for acute diverticulitis with peritonitis: a multicentre intenrnational randomised open trial
Sahlgrenska University Hospital (Sweden) - Department of Surgery0 个研究点目标入组 80 人开始时间: 2009年11月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with acute diverticulitis (no age limits, either sex)
- •2. Intra-abdominal fluid or gas on computed tomography (CT)
- •3. Decision by the surgeon to perform emergency surgery
- •4. Possible to operate in regard to concomitant disease
- •5. Informed consent
- •Amended 10/05/2010:
- •The ethical committees have given permission for patients who are unable to give informed consent due to the diverticulitis, to be included until such time postoperatively when they can be duly informed and then give an informed consent or withdraw the presumed consent.
排除标准
- •Current exclusion criteria as of 30/06/2011:
- •1.1. Not possible to operate due to concomitant disease
- •1.2. Participation in other randomized trials in conflict with the protocol and end-points of the DILALA trial
- •2. Randomization: criteria
- •2.1. Perforated diverticulitis Hinchey grad III at diagnostic laparoscopy
- •3. Exclusion from randomization: criteria
- •3.1. Hinchey grade I - II at laparoscopy i.e. no free fluid/pus in the abdomen ? no further surgical procedure
- •3.2. Hinchey grade IV at laparoscopy, i.e. gross faecal contamination will be converted to open surgical procedure with resection and stoma formation
- •3.3. Other pathology than perforated diverticulitis, for example perforated appendicitis or stomach ulcer.
- •4. Exclusion after randomization
- •4.1. Withdrawn consent
- •4.2. Cancer diagnosed in resected specimen (only possible in randomised to Hartmann?s procedure)
- •4.3. Cancer diagnosed at colonoscopy after initial episode
- •5. Intention to treat
- •5.1. All patients randomised in accordance with randomization criteria and not excluded correctly after randomization (criteria for this see above) will be analysed in group of randomization. This means that patients randomized to laparocopic lavage and converted to open surgery will be analysed in the 'laparoscopic lavage group'
- •Previous exclusion criteria:
- •1. Patients not possible to operate due to concomitant disease
- •2. Hinchey grade I - II at laparoscopy i.e. no free fluid - no further surgical procedure
- •3. Hinchey grade IV at laparoscopy, i.e. gross faecal contamination will be converted to open surgical procedure with resection and stoma formation
- •4. Participation in other randomised trials in conflict with the protocol and end-points of this trial
研究者
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