Scandinavian Diverticulitis Trial (SCANDIV)

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ClinicalTrials.gov Identifier: NCT01047462

Recruitment Status : Completed

First Posted : January 13, 2010

Last Update Posted : January 24, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Sykehuset Asker og Baerum

Diakonhjemmet Hospital

Sykehuset Ostfold

Haukeland University Hospital

Sykehuset Innlandet HF

Karolinska University Hospital

University Hospital, Linkoeping

Helse Nord-Trøndelag HF

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

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	Phase
Diverticulitis	Procedure: Surgery for acute perforated diverticulitis	Not Applicable

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

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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
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diverticulosis and Diverticulitis

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 :

90 days complication rate [ Time Frame: 90 days ]

Secondary Outcome Measures :

Quality of life [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

Information from the National Library of Medicine

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

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Norway
Akershus University Hospital
Lorenskog, Norway, 1478

Sponsors and Collaborators

University Hospital, Akershus