Scandinavian Diverticulitis Trial

Not Applicable

Completed

• Conditions: Diverticulitis
• Interventions: Procedure: Surgery for acute perforated diverticulitis

• Registration Number: NCT01047462
• Lead Sponsor: University Hospital, Akershus

Brief Summary

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.

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Primary Completion: 2014-10
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic lavage	Surgery for acute perforated diverticulitis	-
Primary resection	Surgery for acute perforated diverticulitis	-

Primary Outcome Measures

Name	Time	Method
90 days complication rate	90 days

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 year

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lorenskog, Norway