Scandinavian Diverticulitis Trial (SCANDIV)

January 23, 2017 updated by: Tom Oresland, University Hospital, Akershus

Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Lorenskog, Norway, 1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
90 days complication rate
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Collaborators

Karolinska University Hospital
Ullevaal University Hospital
Diakonhjemmet Hospital
Helse Stavanger HF
Haukeland University Hospital
Sykehuset Innlandet HF
Helse Nord-Trøndelag HF
University Hospital, Linkoeping
Skane University Hospital
Sykehuset Ostfold
Uppsala University Hospital
Helsingborgs Hospital
Sykehuset Buskerud HF
Sykehuset Asker og Baerum
Helse Nord
Centrallasarettet Västerås
Helse Nordmøre og Romsdal
Vrinnevisjukhuset i Norrköping
Eskilstuna Lasarettet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/177 (REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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