Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Short-term Mortality
研究概览
简要总结
Laparoscopic peritoneal lavage (LPL) has recently been emerging as an effective alternative to laparoscopic sigmoidectomy (LS) in patients with complicated acute diverticulitis (CAD) (Modified Hinchey's classification grade II non-responder to conservative therapy and grade III). Aim of the study is to evaluate which surgical strategy, between LPL and LS, could give better results in patients with CAD
详细描述
In the literature, there is no consensus about the role of the laparoscopic peritoneal lavage in the management of complicated acute diverticulitis. Recently, three important prospective randomized-control studies (SCANDIV, LOLA, DILALA) have reported contradicting conclusions, as two of them (SCANDIV and LOLA) state that LPL is not superior to sigmoidectomy for the high reoperation rate and morbidity, while DILALA confirms that LPL is feasible and safe in the short-term. To our knowledge, no international guidelines promote the use of LPL in complicated acute diverticulitis. We believe this technique could be safely used in a selected cohort of patients and, in some circumstances, could represent a "bridge" to a possible planned resection. The aim of the study is to collect and analyze the multicentric data of the LPL and LS and give a substantial contribution to the scientific community about this very debated topic.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Acute abdominal pain,
- •Signs of localized or diffuse peritonitis
- •Signs of suspected perforated diverticulitis (diagnostic imaging)
- •Signed informed consent
排除标准
- •Septic shock
- •Immunodepression
- •Previous multiple abdominal surgical operations
- •Modified Hinchey's grade IV
结局指标
主要结局
Short-term Mortality
时间窗: 30 days
Optimal Sepsis Control
时间窗: 30 days
Short-term Morbidity
时间窗: 30 days
Post-operative Re-interventions Rate
时间窗: 15 days
次要结局
- Mean Postoperative Time(1 day)
- Recurrent Colonic Diverticulitis Rate(6 months)
- Average Length of Postoperative Hospital Stay(30 day)
- Incisional Hernia Rate(6 months)
研究者
Dario Tartaglia
MD, PhD Candidate
Azienda Ospedaliero, Universitaria Pisana
