Clinical Trial: LapLAND Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis
Brief Summary:
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
Detailed Summary:
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 laparos
Sponsor: St Vincent's University Hospital, Ireland
Current Primary Outcome: Operative and in-hospital mortality [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- In-hospital and post-discharge morbidity [ Time Frame: 1 year ]
- Rates of stoma formation [ Time Frame: 1 year ]
- Rates of re-presentation with diverticulitis with or without perforation [ Time Frame: 1 year ]
Original Secondary Outcome: Same as current
Information By: St Vincent's University Hospital, Ireland
Dates:
Date Received: November 23, 2009
Date Started: January 2010
Date Completion: December 2015
Last Updated: November 30, 2009
Last Verified: November 2009
