Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Operative and in-hospital mortality
研究概览
简要总结
The aim of the study is to compare patient outcome following standard of care (Hartmann's or resection with anastomosis and defunctioning stoma) and a 'new therapy' (laparoscopic lavage alone) for the treatment of acute perforated non-faeculant diverticulitis in Irish hospitals.
Perforated diverticulitis requires emergency surgery. This carries significant risks and mortality as high as 15% during the index admission has been reported. Our group has established the safety of laparoscopic lavage alone on the largest cohort to date in a prospective multi-institutional study of 100 patients, providing convincing evidence that laparoscopic lavage alone is a reasonable alternative to resection for non-faeculant perforated diverticulitis. Our aim now is to translate this well-established study design into a protocol for a multi-institutional randomised control trial as direct comparison is the only way to provide convincing evidence of one modality over another.
All patients will be followed up for twelve months and primary (operative and in-hospital mortality) and secondary (in-hospital and post-discharge morbidity; rates of stoma formation; rates of re-presentation with diverticulitis with or without perforation.) end-points will be recorded.
Sample size calculations reveal that a patient cohort of 100 in each arm will be sufficient to detect a difference in morbidity and mortality between groups The ratio between Hinchey 3 and Hinchey 4 is estimated to be approximately 2:1. In order to guarantee sufficient sample size, therefore, 300 patients must fulfil the study criteria allowing for exclusion of 100 at time of operation
详细描述
Background and Current Knowledge:
Until recently, the natural history of diverticular disease was poorly understood and evidence suggesting a link between recurrent presentations with diverticulitis and perforation is almost forty years old rendering its relevance to modern day practice questionable at best . More recently, these questions have been clarified and it seems that risk of perforation following a single (treated) episode of diverticulitis is in the order of 2% per year with a risk of requiring an emergency Hartmann's procedure in this cohort being 1 in 2000 patient years of follow-up . As with all surgical interventions, there is a certain risk profile associated with elective resection and morbidity is estimated at 25-50% (including stoma formation in 10-14%) and mortality at 1-2% . The current vogue (despite some dissention ) is towards a more conservative approach to management of non-perforated acute diverticulitis and away from elective sigmoid colectomy in the absence of perforation .
Management of perforated diverticulitis continues to evolve. The last 50 years has seen standard of care shift from a three stage procedure (1.Drainage and defunctioning colostomy, 2.Excision of diseased segment, 3.Colostomy reversal and restoration of continuity) , to Hartmann's procedure , to resection and primary anastomosis , to treatment with antimicrobial therapy alone in a carefully selected (Hinchey Grade 2) population . Since the learning curve for laparoscopic surgery has begun to plateau, resections for perforated diverticular disease have been shown to be as safe and effective as conventional open techniques .
Irish surgeons have pioneered the institution of laparoscopic lavage for acute non-faeculant diverticulitis. The operative method described involves laparoscopy, copious washout, drain placement and treatment with antimicrobial therapy (intravenous for 72hours followed by oral for one week). Benefits include low mortality, stoma avoidance, minimal wound infection, shorter operative time and no difference in recurrence when compared to primary resection and anastomosis. Having demonstrated a clear clinical advantage of laparoscopic lavage over standard of care (Hartmann's procedure or primary resection and anastomosis) for acute non faeculant perforated diverticulitis, we feel the time is ripe to formalise these findings through performance of a multicentre national randomised controlled trial- LapLAND (LAParoscopic Lavage for Acute Non-faeculant Diverticulitis).
Relevance:
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years..
- •Clinical evidence of generalised peritonitis.
- •Free air on erect chest x-ray or CT abdomen suggestive of perforated diverticulitis.
- •Informed consent.
排除标准
- •Inability to give informed consent (eg dementia).
- •Prior sigmoidectomy.
- •Ongoing steroid treatment >20mg/day.
- •Prior pelvic irradiation.
- •Requirement for inotropic support pre-operatively.
- •Faecal peritonitis or overt sigmoid perforation (demonstrated on laparoscopy).
结局指标
主要结局
Operative and in-hospital mortality
时间窗: 1 year
次要结局
- Rates of re-presentation with diverticulitis with or without perforation(1 year)
- In-hospital and post-discharge morbidity(1 year)
- Rates of stoma formation(1 year)
