Scandinavian Diverticulitis Trial

Diverticulitis Clinical Trial

— SCANDIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047462
• Other study ID #: 2009/177 (REK)
• Status: Completed
• Phase: N/A
• First received: January 12, 2010
• Last updated: January 23, 2017
• Start date: January 2010
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis

Intervention

Procedure:
• Surgery for acute perforated diverticulitis
Primary resection vs laparoscopic lavage

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog

Sponsors (20)

Lead Sponsor

Collaborator

University Hospital, Akershus

Centrallasarettet Västerås, Diakonhjemmet Hospital, Eskilstuna Lasarettet, Haukeland University Hospital, Helse Nord, Helse Nordmøre og Romsdal, Helse Stavanger HF, Helsingborgs Hospital, Karolinska University Hospital, Levanger Hospital, Skane University Hospital, Sykehuset Asker og Baerum, Sykehuset Buskerud HF, Sykehuset Innlandet HF, Sykehuset Ostfold, Ullevaal University Hospital, University Hospital, Linkoeping, Uppsala University Hospital, Vrinnevisjukhuset i Norrköping

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	90 days complication rate		90 days
Secondary	Quality of life		1 year