title: Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results.
  
  
  METHODS
  DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40).
  
  
  CONCLUSIONS
  HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life.
  
  
  BACKGROUND
  British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.
authors.affiliation: Department of Surgery, Alingsås Hospital, Södra Ringatan, Sweden. anders.thornell@vgregion.se
authors.forename: Anders
authors.initials: A
authors.lastname: Thornell
authors.forename: Eva
authors.initials: E
authors.lastname: Angenete
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Gonzales
authors.forename: Jane
authors.initials: J
authors.lastname: Heath
authors.forename: Per
authors.initials: P
authors.lastname: Jess
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Läckberg
authors.forename: Henrik
authors.initials: H
authors.lastname: Ovesen
authors.forename: Jacob
authors.initials: J
authors.lastname: Rosenberg
authors.forename: Stefan
authors.initials: S
authors.lastname: Skullman
authors.forename: Eva
authors.initials: E
authors.lastname: Haglind
mesh_terms: D000208:Acute Disease; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D003082:Colectomy / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D003125:Colostomy; D003362:Cost-Benefit Analysis; D004239:Diverticulitis, Colonic / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D004322:Drainage; D017048:Health Care Costs; D006801:Humans; D007416:Intestinal Perforation / Q000191:economics / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D010535:Laparoscopy / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D010359:Patient Readmission; D011788:Quality of Life; D012086:Reoperation; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013548:Sweden; D007507:Therapeutic Irrigation / Q000009:adverse effects / Q000191:economics / Q000379:methods* / Q000401:mortality; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents