Laparoscopic peritoneal lavage or sigmoidectomy for @entity4436 with XXXX : a multicentre, parallel-group, randomised, open-label trial.

@entity1 @entity1344 @entity254 @entity4436 @entity298 @entity479
BACKGROUND: Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in @entity1 with @entity4436 . We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in @entity1 with purulent @entity4436 , with respect to overall long-term morbidity and mortality. METHODS: We did a multicentre, parallel-group, randomised, open-label trial in 34 teaching hospitals and eight academic hospitals in Belgium, Italy, and the Netherlands (the Ladies trial). The Ladies trial is split into two groups: the LOLA group comparing laparoscopic lavage with sigmoidectomy and the DIVA group comparing Hartmann's procedure with sigmoidectomy plus primary @entity254 . The DIVA section of this trial is still underway but here we report the results of the LOLA section. @entity1 with purulent @entity4436 were enrolled for LOLA, excluding @entity1 with @entity298 , aged older than 85 years, with high-dose @entity479 use (>= 20 mg daily), and @entity1344 . @entity1 were randomly assigned (2:1:1; stratified by age [<60 years vs >= 60 years]) using secure online computer randomisation to laparoscopic lavage, Hartmann's procedure, or primary @entity254 in a parallel design after diagnostic laparoscopy. @entity1 were analysed according to a modified intention-to-treat principle and were followed up after the index operation at least once in the outpatient setting and after sigmoidoscopy and stoma reversal, according to local protocols. The primary endpoint was a composite endpoint of major morbidity and mortality within 12 months. This trial is registered with ClinicalTrials.gov, number NCT01317485. FINDINGS: Between July 1, 2010, and Feb 22, 2013, 90 @entity1 were randomly assigned in the LOLA section of the Ladies trial when the study was terminated by the data and safety monitoring board because of an increased event rate in the lavage group. Two @entity1 were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 @entity1 in the lavage group and 25 (60%) of 42 @entity1 in the sigmoidectomy group (odds ratio 1  28, 95% CI 0  54-3  03, p=0  58). By 12 months, four @entity1 had died after lavage and six @entity1 had died after sigmoidectomy (p=0  43). INTERPRETATION: Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent @entity4436 . FUNDING: Netherlands Organisation for Health Research and Development.
