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Completed

NCT Number: NCT01047462

Scandinavian Diverticulitis 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus University Hospital

Lorenskog, 1478, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery for acute perforated diverticulitis

Procedure

Primary resection vs laparoscopic lavage

Other names: Hartmann's procedure, Acute diverticulitis, Laparoscopic lavage, Primary resection

Primary outcomes

  1. 90 days complication rate

    Time frame: 90 days

Secondary outcomes

  1. Quality of life

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • Centrallasarettet Västerås
  • Diakonhjemmet Hospital
  • Eskilstuna Lasarettet
  • Haukeland University Hospital
  • Helse Nord
  • Helse Nord-Trøndelag HF
  • Helse Nordmøre og Romsdal
  • Helse Stavanger HF
  • Helsingborgs Hospital
  • Karolinska University 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

Registry information

Official study title

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

Acronym: SCANDIV

Important dates

Study start
2010
Primary completion
2014
Study completion
2016
First posted
Jan 13, 2010
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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