Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

  • Anders Thornell
  • Eva Angenete
  • Elisabeth Gonzales
  • Jane Heath
  • Per Jess
  • Zoltan Läckberg
  • Henrik Ovesen
  • Rosenberg, Jacob
  • Stefan Skullman
  • Eva Haglind
  • Scandinavian Surgical Outcome Research Group Ssorg
  • Anders Thornell
  • Eva Angenete
  • Elisabeth Gonzales
  • Jane Heath
  • Per Jess
  • Zoltan Läckberg
  • Henrik Ovesen
  • Rosenberg, Jacob
  • Stefan Skullman
  • Eva Haglind
  • Scandinavian Surgical Outcomes Research Group, SSORG
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).
Discussion: 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 reoperations,
decreased morbidity, mortality, costs and increased quality of life.
OriginalsprogEngelsk
TidsskriftTrials
Vol/bind12
Sider (fra-til)186-90
ISSN1745-6215
DOI
StatusUdgivet - 2011

ID: 33865023