This trial is active, not recruiting.

Condition diverticulitis
Treatment surgery for acute perforated diverticulitis
Sponsor University Hospital, Akershus
Collaborator Sykehuset Asker og Baerum
Start date January 2010
End date October 2014
Trial size 150 participants
Trial identifier NCT01047462, 2009/177 (REK)


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
surgery for acute perforated diverticulitis Hartmann's procedure
Primary resection vs laparoscopic lavage
(Active Comparator)
surgery for acute perforated diverticulitis Hartmann's procedure
Primary resection vs laparoscopic lavage

Primary Outcomes

90 days complication rate
time frame: 90 days

Secondary Outcomes

Quality of life
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial
Principal investigator Tom Oresland, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Hospital, Akershus.