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Scandinavian Diverticulitis Trial (SCANDIV)

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Tom Oresland, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01047462
First received: January 12, 2010
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
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 Intervention
Diverticulitis Procedure: Surgery for acute perforated diverticulitis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial

Resource links provided by NLM:


Further study details as provided by Tom Oresland, University Hospital, Akershus:

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

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

Estimated Enrollment: 150
Actual Study Start Date: January 2010
Study Completion Date: December 2016
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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)
Study First Received: January 12, 2010
Last Updated: January 23, 2017

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

ClinicalTrials.gov processed this record on July 26, 2017