Laparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial

Sigmoid resection for acute perforated diverticulitis is, regardless of
strategy, associated with substantial moribidity (up to 50%) and mortalitiy (15
to 25%). Just recently, excellent results were reported with laparoscopic
lavage and drainage only, in patients with purulent peritonitis. Mortality and
morbidity figures were less than 5%, and a colostomy was avoided in the
majority of these patients. Potentially, this alternative brings a large gain
in health and reduction of costs. Nevertheless, since sigmoidectomy is still
considered the standard of care for perforated diverticulitis by most surgeons,
implemention might be variabloe. If it is decided to perform a sigmoidectomy
for perforated diverticulitis, the optimal strategy is still subject of debate.
The available literature suggests equality of sigmoid resection with or without
anastomosis regarding postoperative mortality and morbidity. If a sigmoidectomy
with anastomosis is done, a protective loop-ileostomy probably diminishes the
number of anastomotic leakages and its complications. The available literature
suggests that the likelihood of stoma closure is higher after resection,
anastomosis and ileostomy (90%) in comparison to Hartmann's with colostomy
(60%), but evidence is lacking.

The first objective of this integrated trial (LOLA) is to determine whether
laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy
in patients with perforated diverticulitis with purulent peritonitis in terms
of mortality and morbidity.
The second objective (DIVA) is to determine whether sigmoidectomy with
anastomosis and ileostomy or sigmoidectomy with end-colostomy is the superior
approach in patients with perforated diverticulitis with either purulent or
feculent peritonitis in terms of stoma free survival.

The design of the study is randomised and multicenter. Patients presenting with
signs of generalised peritonitis will have a CT-scan. If there is free
intra-abdominal air with suspicion of perforated diverticulitis, the patient is
potentially eligible for this study. If the in- and exclusion criteria are
fulfilled, the patient will have a diagnostic laparoscopy to confirm the
diagnosis. In case of purulent peritonitis the patients enters the LOLA arm of
the study, in case of faecal peritonitis, the patient enters the DIVA arm of
the study. Randomisation is performed during laparoscopy via the trial website.
In case of purulent diverticulitis laparoscopic lavage is compared with either
sigmoidectomy with colostomy or sigmoidectomy with anastomosis with
defunctioning loop ileostomy (LOLA). The best evidence indicates that the
latter two resectional strategies are equal in terms of morbidity and mortality
in case of generalised peritonitis. For this reason a three way 2:1:1
randomisation is proposed. In case of faecal peritonitis or an overt
perforation of the sigmoid, the patient will be randomised in the DIVA arm of
this study. In this way all patients with perforated diverticulitis fulfilling
the in/exclusion criteria can be included in this study.

In case of purulent diverticulitis laparoscopic lavage is compared with either
sigmoidectomy with colostomy or sigmoidectomy with anastomosis with
defunctioning loop ileostomy (LOLA arm). In case of faecal peritonitis or an
overt perforation of the sigmoid, the patient will be randomised in the DIVA
arm of this study to undergo either sigmoidectomy with colostomy or
sigmoidectomy with anastomosis with defunctioning loop ileostomy.

(a) Patients participating in the LOLA arm of the trial undergoing laparoscopic
lavage are at risk of not showing any clincical progress postoperatively and
thus needing reoperation with sigmoidectomy. The benefit of this group is a
possible reduced morbidity and mortality, the abscense of any stoma, a
diminished hospital stay, lower incisional hernia rate and a higher quality of
life.
(b) Patients in both arms of the trial treated with sigmoidectomy with primary
anastomosis and ileostomy are at risk for reoperation as well, thereby
undergoing Hartmann's procedure with end-colostomy, followed by a possible
second stage operation for stoma removal.