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SCANDIV: Scandinavian Diverticulitis Trial

Sponsor
University Hospital, Akershus (Other)
Overall Status
Completed
CT.gov ID
NCT01047462
Collaborator
Sykehuset Asker og Baerum (Other), Diakonhjemmet Hospital (Other), Sykehuset Ostfold (Other), Haukeland University Hospital (Other), Sykehuset Innlandet HF (Other), Karolinska University Hospital (Other), University Hospital, Linkoeping (Other), Helse Nord-Trøndelag HF (Other), Skane University Hospital (Other), Helse Nordmøre og Romsdal (Other), Ullevaal University Hospital (Other), Helse Stavanger HF (Other), Helse Nord (Industry), Uppsala University Hospital (Other), Centrallasarettet Västerås (Other), Sykehuset Buskerud HF (Other), Helsingborgs Hospital (Other), Vrinnevisjukhuset i Norrköping (Other), Eskilstuna Lasarettet (Other)
150
Enrollment
1
Location
2
Arms
83
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

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
  • Procedure: Surgery for acute perforated diverticulitis
 N/A

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
Anticipated 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 :
Jan 1, 2010
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Dec 1, 2016

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 [90 days]

    Secondary Outcome Measures

    1. Quality of life [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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
    • 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

    Investigators

    • Principal Investigator: Tom Oresland, M.D., Ph.D., University Hospital, Akershus

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tom Oresland, Professor, University Hospital, Akershus
    ClinicalTrials.gov Identifier:
    NCT01047462
    Other Study ID Numbers:
    • 2009/177 (REK)
    First Posted:
    Jan 13, 2010
    Last Update Posted:
    Jan 24, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Diverticulitis

    Study Results

    No Results Posted as of Jan 24, 2017