DIverticulitis- LAparoscopic LAvage vs resection (Hartman procedure) for acute diverticulitis with peritonitis (DILALA)

 

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.

The hypothesis

Laparoscopic lavage is feasible and safe and will result in less re-operations within 12 months

Endpoints

Primary:

Rate of re-operation within 12 months of emergency operation.

Secondary:

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.

Inclusion/exclusion

Inclusion criteria:

-       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)

Exclusion criteria:

-       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

Inclusion of patients:

Full accrual 83 patients by February 2014

Participating hospitals

Sweden: Sahlgrenska Universitetssjukhuset, Kärnsjukhuset i Skövde, Norra Älvsborgs Länssjukhus, Centralsjukhuset i Karlstad, Alingsås Lasarett.

Denmark: Herlev Hospital, Holbæk Sygehus, Køge Sygehus, Svendborg Sygehus.

Documents

Protocol (click name to download): DILALA

Publications:

- Angenete 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 2016 Feb 2;164(3):137-45.

- Gehrman, J., Angenete, E., Björholt, I., Bock, D., 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. doi:10.1002/bjs.10230

- Thornell A, Angenete E, Gonzales E, Heath J, Jess P, Lackberg Z, Ovesen H, Rosenberg J, Skullman S, Haglind E, Scandinavian Surgical Outcomes Research Group: Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial. Trials 2011;12:186.

- Thornell A, Angenete E, Haglind E: Perforated diverticulitis operated at Sahlgrenska University Hospital 2003-2008. Dan Med Bull 2011;58:A4173.

Contact

Principal investigator:

Eva Haglind

Deputy principal investigator:

Jacob Rosenberg

Questions:

PI Eva Haglind (eva.haglind@vgregion.se) or research nurse Jane Heath (jane.heath@vgregion.se)