The aim of this trial is to compare the traditional open emergency resection and colostomy (Hartman’s procedure) with laparoscopic lavage and drainage, for diverticulitis Hinchey grade III, in terms of effects on re-operation rate, other clinical outcome variables, quality of life (QoL) and health economy.
Laparoscopic lavage is feasible and safe and will result in less re-operations within 12 months
Rate of re-operation within 12 months of emergency operation.
Re-admission, Postoperative infections wound or deep infection (abscess formation), Postoperative thrombosis, Other complications, Hernia, Bowel obstruction requiring hospitalisation or operation, Total length of hospital stay (for diverticulitis and complications) during 12 months, Quality of life, Health economy analysis, Re-operation during primary hospitalisation , Mortality within 30 days of primary operation, Mortality within 12 months, Permanent stoma (stoma at 12 months postoperatively), Re-admissions and re-operations registered in including hospital database at 24 months.
- Patients with suspected acute diverticulitis with intra-abdominal fluid or gas on CT or a simple X-ray of the abdomen
- A decision by the surgeon to perform emergency surgery
- Possible to operate in regard to concomitant disease
- Giving informed consent to participate (in Sweden also patients unable to give informed consent due to the emergent situation, see above)
- Not possible to operate due to concomitant disease
- Participation in other randomized trials in conflict with the protocol and end-points of the DILALA trial
Full accrual 83 patients by February 2014
Sweden: Sahlgrenska Universitetssjukhuset, Kärnsjukhuset i Skövde, Norra Älvsborgs Länssjukhus, Centralsjukhuset i Karlstad, Alingsås Lasarett.
Denmark: Herlev Hospital, Holbæk Sygehus, Køge Sygehus, Svendborg Sygehus.
Angente E, Thornell A, Pommergaard HC, Burchvald J, Rosenberg J, Haglind E. Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis. The First Results From the Randomized Controlled Trial DILALA. Ann Surg 2016;263:117-22
Thornell A, Angenete E, Bisgaard T, Bock D, Burchart J, Heath J, Pommergaard HC. Rosenberg J, Stilling N, Skullman S, Haglind E. Laparoscopic lavage as treatment for perforated diverticulitis with purulent peritonitis (DILALA): a randomized controlled trial. Ann Int Med 2016 Feb 2;164(3):137-45.
Kohl A, Rosenberg J, Bock D, Bisgaard T, Skullman S, Thornell A, Gehrman J, Angenete E, Haglind E. Treatment of acute diverticulitis with laparoscopic lavage vs. resection: two-year follow-up of a randomized clinical trial (DILALA). Submitted July 2017.
Angenete E, Bock D, Rosenberg J, Haglind E. Laparoscopic lavage versus colon resection for perforated purulent diverticulitis - a meta-analysis. Int J Colorectal Dis DOI 10.1007/s00384-016-2636-0
Gehrman J, Björholt I, AngeneteE, Rosenberg J, Haglind E. Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial. Br J Surg. 2016 Oct;103(11):1539-47
Thornell A, Angenete E, Gonzales E, Heath J, Jess P, Läckberg Z, Ovesen H, Rosenberg J, Skullman S, Haglind E. Treatment of acute diverticulitis: laparoscopic lavage vs. resection (DILALA): a study protocol for a randomised controlled trial. Trials. 2011;12:186
PI Eva Haglind (firstname.lastname@example.org) or research nurse Jane Heath (email@example.com)