title: Laparoscopic peritoneal lavage or sigmoidectomy for perforated diverticulitis with purulent peritonitis: a multicentre, parallel-group, randomised, open-label trial.
abstract: BACKGROUND
  Case series suggest that laparoscopic peritoneal lavage might be a promising alternative to sigmoidectomy in patients with perforated diverticulitis. We aimed to assess the superiority of laparoscopic lavage compared with sigmoidectomy in patients with purulent perforated diverticulitis, 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 anastomosis. The DIVA section of this trial is still underway but here we report the results of the LOLA section. Patients with purulent perforated diverticulitis were enrolled for LOLA, excluding patients with faecal peritonitis, aged older than 85 years, with high-dose steroid use (≥20 mg daily), and haemodynamic instability. Patients 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 anastomosis in a parallel design after diagnostic laparoscopy. Patients 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.
  
  
  RESULTS
  Between July 1, 2010, and Feb 22, 2013, 90 patients 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 patients were excluded for protocol violations. The primary endpoint occurred in 30 (67%) of 45 patients in the lavage group and 25 (60%) of 42 patients in the sigmoidectomy group (odds ratio 1·28, 95% CI 0·54-3·03, p=0·58). By 12 months, four patients had died after lavage and six patients had died after sigmoidectomy (p=0·43).
  
  
  CONCLUSIONS
  Laparoscopic lavage is not superior to sigmoidectomy for the treatment of purulent perforated diverticulitis.
  
  
  BACKGROUND
  Netherlands Organisation for Health Research and Development.
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, Netherlands; Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
authors.forename: Sandra
authors.initials: S
authors.lastname: Vennix
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Gijsbert D
authors.initials: GD
authors.lastname: Musters
authors.affiliation: Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
authors.forename: Irene M
authors.initials: IM
authors.lastname: Mulder
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Hilko A
authors.initials: HA
authors.lastname: Swank
authors.affiliation: Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands.
authors.forename: Esther C
authors.initials: EC
authors.lastname: Consten
authors.affiliation: Department of Surgery, Atrium Medical Centre, Heerlen, Netherlands.
authors.forename: Eric H
authors.initials: EH
authors.lastname: Belgers
authors.affiliation: Department of Surgery, Tergooi Hospital, Hilversum, Netherlands.
authors.forename: Anna A
authors.initials: AA
authors.lastname: van Geloven
authors.affiliation: Department of Surgery, OLVG Hospital, Amsterdam, Netherlands.
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gerhards
authors.affiliation: Department of Surgery, Westfriesgasthuis, Hoorn, Netherlands.
authors.forename: Marc J
authors.initials: MJ
authors.lastname: Govaert
authors.affiliation: Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands.
authors.forename: Wilhelmina M
authors.initials: WM
authors.lastname: van Grevenstein
authors.affiliation: Department of Surgery, Orbis Medical Centre, Sittard, Netherlands.
authors.forename: Anton G
authors.initials: AG
authors.lastname: Hoofwijk
authors.affiliation: Department of Surgery, Gelderse Vallei Hospital, Ede, Netherlands.
authors.forename: Philip M
authors.initials: PM
authors.lastname: Kruyt
authors.affiliation: Department of Surgery, Catharina Hospital, Eindhoven, Netherlands.
authors.forename: Simon W
authors.initials: SW
authors.lastname: Nienhuijs
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Marja A
authors.initials: MA
authors.lastname: Boermeester
authors.affiliation: Department of Surgery, Kennemer Hospital, Haarlem, Netherlands.
authors.forename: Jefrey
authors.initials: J
authors.lastname: Vermeulen
authors.affiliation: Clinical Research Unit, Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Susan
authors.initials: S
authors.lastname: van Dieren
authors.affiliation: Department of Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
authors.forename: Johan F
authors.initials: JF
authors.lastname: Lange
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, Netherlands. Electronic address: w.a.bemelman@amc.nl.
authors.forename: Willem A
authors.initials: WA
authors.lastname: Bemelman
mesh_terms: D012809:Colon, Sigmoid / Q000601:surgery*; D004239:Diverticulitis, Colonic / Q000150:complications / Q000601:surgery* / Q000628:therapy; D005260:Female; D006801:Humans; D007416:Intestinal Perforation / Q000209:etiology / Q000601:surgery*; D010535:Laparoscopy; D008297:Male; D008875:Middle Aged; D010533:Peritoneal Lavage; D010538:Peritonitis / Q000209:etiology / Q000601:surgery*; D016896:Treatment Outcome