Scandinavian Diverticulitis Trial
This trial is active, not recruiting.
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
90 days complication rate
time frame: 90 days
Quality of life
time frame: 1 year
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
|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.|
Call for more information