Clinical trial NCT01047462: Scandinavian Diverticulitis Trial
Official title: Scandinavian Diverticulitis Trial. Laparoscopic Lavage vs Primary Resection as Treatment for Perforated Diverticulitis. A Randomized Prospective Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diverticulitis
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Sykehuset Asker og Baerum
name: Diakonhjemmet Hospital
name: Sykehuset Ostfold
name: Haukeland University Hospital
name: Sykehuset Innlandet HF
name: Karolinska University Hospital
name: University Hospital, Linkoeping
name: Helse Nord-Trøndelag HF
name: Skane University Hospital
name: Helse Nordmøre og Romsdal
name: Ullevaal University Hospital
name: Helse Stavanger HF
name: Helse Nord
name: Uppsala University Hospital
name: Centrallasarettet Västerås
name: Sykehuset Buskerud HF
name: Helsingborgs Hospital
name: Vrinnevisjukhuset i Norrköping
name: Eskilstuna Lasarettet
First posted: 2010-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 90 days complication rate
timeFrame: 90 days
Secondary outcomes:
measure: Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Lorenskog
country: Norway
facility: Akershus University Hospital
Study officials:
affiliation: University Hospital, Akershus
name: Tom Oresland, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.