Scandinavian Diverticulitis Trial (SCANDIV)
Primary Purpose
Diverticulitis
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Surgery for acute perforated diverticulitis
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulitis
Eligibility 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
Sites / Locations
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Laparoscopic lavage
Primary resection
Arm Description
Outcomes
Primary Outcome Measures
90 days complication rate
Secondary Outcome Measures
Quality of life
Full Information
NCT ID
NCT01047462
First Posted
January 12, 2010
Last Updated
January 23, 2017
Sponsor
University Hospital, Akershus
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
1. Study Identification
Unique Protocol Identification Number
NCT01047462
Brief Title
Scandinavian Diverticulitis Trial
Acronym
SCANDIV
Official Title
Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
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
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparoscopic lavage
Arm Type
Active Comparator
Arm Title
Primary resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Surgery for acute perforated diverticulitis
Other Intervention Name(s)
Hartmann's procedure, Acute diverticulitis, Laparoscopic lavage, Primary resection
Intervention Description
Primary resection vs laparoscopic lavage
Primary Outcome Measure Information:
Title
90 days complication rate
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Oresland, M.D., Ph.D.
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lorenskog
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
33355658
Citation
Azhar N, Johanssen A, Sundstrom T, Folkesson J, Wallon C, Korner H, Blecic L, Forsmo HM, Oresland T, Yaqub S, Buchwald P, Schultz JK; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: Long-term Outcomes From the Scandinavian Diverticulitis (SCANDIV) Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):121-127. doi: 10.1001/jamasurg.2020.5618. Erratum In: JAMA Surg. 2021 Sep 1;156(9):894.
Results Reference
derived
PubMed Identifier
28631827
Citation
Schultz JK, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T, Yaqub S; SCANDIV Study Group. One-year results of the SCANDIV randomized clinical trial of laparoscopic lavage versus primary resection for acute perforated diverticulitis. Br J Surg. 2017 Sep;104(10):1382-1392. doi: 10.1002/bjs.10567. Epub 2017 Jun 20.
Results Reference
derived
PubMed Identifier
26441181
Citation
Schultz JK, Yaqub S, Wallon C, Blecic L, Forsmo HM, Folkesson J, Buchwald P, Korner H, Dahl FA, Oresland T; SCANDIV Study Group. Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: The SCANDIV Randomized Clinical Trial. JAMA. 2015 Oct 6;314(13):1364-75. doi: 10.1001/jama.2015.12076.
Results Reference
derived
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Scandinavian Diverticulitis Trial
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