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Scandinavian Diverticulitis Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01047462
Acronym
SCANDIV
Enrollment
150
Registered
2010-01-13
Start date
2010-01-31
Completion date
2016-12-31
Last updated
2017-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diverticulitis

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.

Interventions

PROCEDURESurgery for acute perforated diverticulitis

Primary resection vs laparoscopic lavage

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
90 days complication rate90 days

Secondary

MeasureTime frame
Quality of life1 year

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026