跳至主要内容
临床试验/NCT03008707
NCT03008707已完成不适用

Laparoscopic Peritoneal Lavage vs Laparoscopic Sigmoidectomy in Perforated Acute Diverticulitis: a Multicenter Prospective Observational Study

Azienda Ospedaliero, Universitaria Pisana1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dario Tartaglia

MD, PhD Candidate

Azienda Ospedaliero, Universitaria Pisana

研究点 (1)

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