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Scandinavian Diverticulitis Trial (SCANDIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01047462
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Diverticulitis Procedure: Surgery for acute perforated diverticulitis

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial
Actual Study Start Date : January 2010
Primary Completion Date : October 2014
Study Completion Date : December 2016

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Laparoscopic lavage Procedure: Surgery for acute perforated diverticulitis
Primary resection vs laparoscopic lavage
Other Names:
  • Hartmann's procedure
  • Acute diverticulitis
  • Laparoscopic lavage
  • Primary resection
Active Comparator: Primary resection Procedure: Surgery for acute perforated diverticulitis
Primary resection vs laparoscopic lavage
Other Names:
  • Hartmann's procedure
  • Acute diverticulitis
  • Laparoscopic lavage
  • Primary resection


Outcome Measures

Primary Outcome Measures :
  1. 90 days complication rate [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01047462


Locations
Norway
Akershus University Hospital
Lorenskog, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
Sykehuset Asker og Baerum
Diakonhjemmet Hospital
Sykehuset Ostfold
Haukeland University Hospital
Sykehuset Innlandet HF
Karolinska University Hospital
University Hospital, Linkoeping
Levanger Hospital
Skane University Hospital
Helse Nordmøre og Romsdal
Ullevaal University Hospital
Helse Stavanger HF
Helse Nord
Uppsala University Hospital
Centrallasarettet Västerås
Sykehuset Buskerud HF
Helsingborgs Hospital
Vrinnevisjukhuset i Norrköping
Eskilstuna Lasarettet
Investigators
Principal Investigator: Tom Oresland, M.D., Ph.D. University Hospital, Akershus
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tom Oresland, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01047462     History of Changes
Other Study ID Numbers: 2009/177 (REK)
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diverticulitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases