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Scandinavian Diverticulitis Trial (SCANDIV)

This study is currently recruiting participants.
Verified June 2012 by University Hospital, Akershus
Sponsor:
Collaborators:
Borås Lasarett
Danderyd Hospital
Diakonhjemmet Hospital
Sykehuset Ostfold
Helse Fonna
Haukeland University Hospital
Sykehuset Innlandet HF
Karolinska University Hospital
University Hospital, Linkoeping
Levanger Hospital
Skane University Hospital
Helse Nordmøre og Romsdal
University Hospital, Aker
Ullevaal University Hospital
Helse Stavanger HF
Sorlandet Hospital HF
Helse Nord
Uppsala University Hospital
Centrallasarettet Västerås
Sykehuset Buskerud HF
Umeå University Hospital
Information provided by:
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01047462
First received: January 12, 2010
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Akershus:

Primary Outcome Measures:
  • 90 days complication rate [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2013 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047462

Contacts
Contact: Tom Oresland, M.D., Ph.D. +47 915 02900 tom.oresland@medisin.uio.no
Contact: Johannes Schultz, M.D. +47 915 02900 johannes.kurt.schultz@ahus.no

Locations
Norway
Akershus University Hospital Recruiting
Lorenskog, Norway, 1478
Contact: Tom Oresland, M.D., Ph.D.     +47 915 02900     tom.oresland@medisin.uio.no    
Contact: Johannes K Schultz, M.D.     +47 915 02900     johannes.kurt.schultz@ahus.no    
Principal Investigator: Tom Oresland, M.D., Ph.D.            
Sponsors and Collaborators
University Hospital, Akershus
Borås Lasarett
Danderyd Hospital
Diakonhjemmet Hospital
Sykehuset Ostfold
Helse Fonna
Haukeland University Hospital
Sykehuset Innlandet HF
Karolinska University Hospital
University Hospital, Linkoeping
Levanger Hospital
Skane University Hospital
Helse Nordmøre og Romsdal
University Hospital, Aker
Ullevaal University Hospital
Helse Stavanger HF
Sorlandet Hospital HF
Helse Nord
Uppsala University Hospital
Centrallasarettet Västerås
Sykehuset Buskerud HF
Umeå University Hospital
Investigators
Principal Investigator: Tom Oresland, M.D., Ph.D. University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Tom Oresland, Professor, M.D., Ph. D, Akershus University Hospital
ClinicalTrials.gov Identifier: NCT01047462     History of Changes
Other Study ID Numbers: 2009/177 (REK)
Study First Received: January 12, 2010
Last Updated: June 8, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013