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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
University Hospital, Akershus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticulitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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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