Scandinavian Diverticulitis Trial

Overview

The purpose of this study is to determine whether laparoscopic lavage changes the rate of severe complications in patients with acute perforated diverticulitis who traditionally are treated with primary resection.

Full Title of Study: “Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Detailed Description

Acute diverticulitis is a common disease in the western world. Perforation of the acute diverticulitis with peritonitis is a feared complication and standard treatment (primary sigmoid resection such as Hartmann`s procedure) still has unsatisfactory results. Both mortality and morbidity are quite high. Several uncontrolled trials have reported a lower mortality and morbidity when acute perforated diverticulitis is treated with laparoscopic lavage instead of radical surgery. The investigators wish to conduct a randomized multicenter trial in Scandinavia in order to compare the rates of severe postoperative complications in acute perforated diverticulitis if treated by traditional primary sigmoid resection or by laparoscopic lavage. The investigators are planning to include all patients admitted to the participating hospitals with clinical and radiological findings of acute perforated diverticulitis.

Interventions

  • Procedure: Surgery for acute perforated diverticulitis
    • Primary resection vs laparoscopic lavage

Arms, Groups and Cohorts

  • Active Comparator: Laparoscopic lavage
  • Active Comparator: Primary resection

Clinical Trial Outcome Measures

Primary Measures

  • 90 days complication rate
    • Time Frame: 90 days

Secondary Measures

  • Quality of life
    • Time Frame: 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • age over 18
  • clinical suspicion of perforated diverticulitis with indication for urgent surgery
  • CT scan with free air and findings suggesting diverticulitis
  • patient tolerates general anaesthesia
  • patients written consent

Exclusion Criteria

  • pregnancy
  • bowel obstruction

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Akershus
  • Collaborator
    • Sykehuset Asker og Baerum
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tom Oresland, Professor – University Hospital, Akershus
  • Overall Official(s)
    • Tom Oresland, M.D., Ph.D., Principal Investigator, University Hospital, Akershus

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