DiverticulitisSCANDIVNCT01047462
Scandinavian Diverticulitis Trial
A study testing Surgery for acute perforated diverticulitis in people with Diverticulitis, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Surgery for acute perforated diverticulitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2010to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- bowel obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diverticulitis
- Being tested
- Surgery for acute perforated diverticulitis
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for acute perforated diverticulitisProcedure or surgery
Also called Hartmann's procedure, Acute diverticulitis, Laparoscopic lavage, Primary resection
Primary resection vs laparoscopic lavage
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic lavage | Active comparator | Not described Receives: Procedure: Surgery for acute perforated diverticulitis |
| Primary resection | Active comparator | Not described Receives: Procedure: Surgery for acute perforated diverticulitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 days complication rate
Measured: 90 days
Secondary outcomes (1)
Quality of life
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2014
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Tom Oresland, University Hospital, Akershus
- Investigators
- Tom Oresland, M.D., Ph.D., Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047462
- Sponsor's protocol ID
- 2009/177 (REK)
- Acronym
- SCANDIV
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2010
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33355658Schultz 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.
PubMed 28631827Schultz 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.
PubMed 26441181
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial
- ClinicalTrials.gov ID
- NCT01047462
- Acronym / sponsor ID
- SCANDIV / 2009/177 (REK)
- Conditions
- Diverticulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- 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
- Study start
- Jan 2010 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic lavage | Active comparator | Procedure: Surgery for acute perforated diverticulitis |
| Primary resection | Active comparator | Procedure: Surgery for acute perforated diverticulitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- pregnancy
- bowel obstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for acute perforated diverticulitisAlso: Hartmann's procedure, Acute diverticulitis, Laparoscopic lavage, Primary resectionPrimary resection vs laparoscopic lavage | Procedure or surgery | Laparoscopic lavage, Primary resection |
Primary outcome
90 days complication rate
Time frame: 90 days
1 secondary outcome
Quality of life
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Derived from this study: PubMed 33355658Azhar 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.
- Derived from this study: PubMed 28631827Schultz 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.
- Derived from this study: PubMed 26441181Schultz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Oresland, M.D., Ph.D. principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery for acute perforated diverticulitis in people with Diverticulitis, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 days complication rate (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01047462, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.