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Clinical Trials/NCT01047462
NCT01047462CompletedNot Applicable

Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial

University Hospital, Akershus2 sites in 1 country150 target enrollmentStarted: January 1, 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
2
Primary Endpoint
90 days complication rate

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

90 days complication rate

Time Frame: 90 days

Secondary Outcomes

  • Quality of life(1 year)

Investigators

Sponsor
University Hospital, Akershus
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tom Oresland

Professor

University Hospital, Akershus

Study Sites (2)

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