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

Anders Thornell, Eva Angenete, Elisabeth Gonzales, Jane Heath, Per Jess, Zoltan Läckberg, Henrik Ovesen, Jacob Rosenberg, Stefan Skullman, Eva Haglind, Scandinavian Surgical Outcome Research Group Ssorg, Anders Thornell, Eva Angenete, Elisabeth Gonzales, Jane Heath, Per Jess, Zoltan Läckberg, Henrik Ovesen, Jacob Rosenberg, Stefan SkullmanEva Haglind, Scandinavian Surgical Outcomes Research Group, SSORG

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    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).
    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

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