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Laparoscopic Peritoneal Lavage or Resection for Generalised Peritonitis for Perforated Diverticulitis: a Nationwide Multicenter Randomised Trial

This study is currently Recruiting

April 2010 By Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

First Recieved on March 16, 2011

Last Updated on March 16, 2011

Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Identifier: NCT01317485

Purpose

The first objective (LOLA) of this integrated trial is to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity. The second objective (DIVA) is to determine whether sigmoidectomy with anastomosis or sigmoidectomy with end-colostomy is the superior approach in patients with perforated diverticulitis with either purulent or faecal peritonitis in terms of stoma free survival. The study is designed as a multicenter and randomised trial. Patients diagnosed as having perforated diverticulitis with free air on plain abdominal X-ray or CT scan fulfilling the in- and exclusion criteria are randomised during laparoscopy via a central computer. In case of purulent diverticulitis patients are randomised to three arms: (a) laparoscopic lavage, (b) sigmoidectomy with colostomy or (c) sigmoidectomy with anastomosis in ratio of 2:1:1. In case of faecal peritonitis or an overt perforation of the sigmoid, the patient will be randomised 1:1 to sigmoidectomy with colostomy or sigmoidectomy with primary anastomosis. The first primary outcome parameter consists of a combined endpoint consisting of mortality and major morbidity (LOLA). The second primary endpoint consists of stoma-free survival one year after initial surgery (DIVA). Secondary endpoints are number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. A sample size of 132:66:66 patients per treatment arm will be able to detect a difference in the combined endpoint of serious complications and mortality from 25% in the two sigmoidectomy groups compared to 10% in the lavage group (two-side alpha of 5% and a power of 90%. In the DIVA analysis 2x132 patients are needed to significantly demonstrate a difference of 30% in stoma-free survival between both treatment arms (log rank test two-sided alpha of 5% and power of 90%) in favour of the patients with primary anastomosis. More than 35 hospitals will participate in this study with an estimated total inclusion of 100 patients per year. Patients will be followed for one year. The study will be executed in concordance with the protocol, the Good Clinical Practice guidelines and regulatory requirements.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: patients suspected of diverticulitis - age in between 18 and 85 years old - with written informed consent - with free air on plain abdominal or thoracic X-ray or CT-scan OR with peritonitis and diffuse gas or fluid on CT-scan Exclusion Criteria: - dementia - prior sigmoidectomy - steroid treatment > 20 mg daily - prior pelvic irradiation - preoperative shock: requirement of inotropics due to circulatory insufficiency

Investigators

  • Investigator: J.F. Lange, Professor - Principal Investigator - Erasmus Medical Centre, Rotterdam
  • Investigator: W.A. Bemelman, Professor - Principal Investigator - Academic Medical Centre, Amsterdam

Locations

  • University Clinic St. Luc

    Brussels, Belgium

  • University Hospital Leuven

    Leuven, Belgium

  • Jeroen Bosch Hospital

    's-Hertogenbosch, Netherlands

  • Flevo Hospital

    Almere, Netherlands

  • Rijnland Hospital

    Alphen aan de Rijn and Leiderdorp, Netherlands

  • Meander Medical Centre

    Amersfoort, Netherlands

  • Academic Medical Centre

    Amsterdam, Netherlands

  • Free University Medical Centre

    Amsterdam, Netherlands

  • Slotervaart Hospital

    Amsterdam, Netherlands

  • Onze Lieve Vrouwe Hospital

    Amsterdam, Netherlands

  • St. Lucas Andreas Hospital

    Amsterdam, Netherlands

  • Alysis Medical Centre

    Arnhem, Netherlands

  • Rode Kruis Hospital

    Beverwijk, Netherlands

  • Amphia Hospital

    Breda, Netherlands

  • IJsselland Hospital

    Capelle aan de IJssel, Netherlands

  • Reinier de Graaf Hospital

    Delft, Netherlands

  • Deventer Hospital

    Deventer, Netherlands

  • Albert Schweitzer Hospital

    Dordrecht and Zwijndrecht, Netherlands

  • Gelderse Vallei Hospital

    Ede, Netherlands

  • Catharina Hospital

    Eindhoven, Netherlands

  • Medical Spectrum Twente

    Enschede, Netherlands

  • Groene Hart Hospital

    Gouda, Netherlands

  • Kennemer Hospital

    Haarlem, Netherlands

  • Atrium Medical Centre

    Heerlen and Brunssum, Netherlands

  • Tergooi Hospitals

    Hilversum and Blaricum, Netherlands

  • Spaarne Hospital

    Hoofddorp, Netherlands

  • Westfries Hospital

    Hoorn, Netherlands

  • Leiden University Medical Centre

    Leiden, Netherlands

  • Maastricht University Medical Centre

    Maastricht, Netherlands

  • St. Antonius Hospital

    Nieuwegein, Netherlands

  • Erasmus Medical Centre

    Rotterdam, Netherlands

  • St. Franciscus Hospital

    Rotterdam, Netherlands

  • Maasstad Hospital

    Rotterdam, Netherlands

  • Ikazia Hospital

    Rotterdam, Netherlands

  • Orbis Medical Centre

    Sittard, Netherlands

  • Haga Hospital

    The Hague, Netherlands

  • Twee Steden Hospital

    Tilburg and Waalwijk, Netherlands

  • University Medical Centre Utrecht

    Utrecht, Netherlands

  • M?xima Medical Centre

    Veldhoven, Netherlands

  • Zaans Medical Centre

    Zaandam, Netherlands

  • Isala Hospitals

    Zwolle, Netherlands

Conditions related to this trial:

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