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Scandinavian Diverticulitis Trial (SCANDIV)

U

University Hospital, Akershus

Status

Completed

Conditions

Diverticulitis

Treatments

Procedure: Surgery for acute perforated diverticulitis

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01047462
2009/177 (REK)

Details and patient eligibility

About

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 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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Laparoscopic lavage
Active Comparator group
Treatment:
Procedure: Surgery for acute perforated diverticulitis
Primary resection
Active Comparator group
Treatment:
Procedure: Surgery for acute perforated diverticulitis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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