LADIES (DIVA): Laparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).
Trial Overview
| Acronym | LADIES (DIVA) |
|---|---|
| Number | NTR2037 |
| Protocol Link | https://www.researchgate.net/publication/47458573_The_ladies_trial_Laparoscopic_peritoneal_lavage_or_resection_for_purulent_peritonitisA_and_Hartmann's_procedure_or_resection_with_primary_anastomosis_for_purulent_or_faecal_peritonitisB_in_perforated_ |
| Public Trial Registry Link | https://clinicaltrials.gov/ct2/show/NCT01317485 |
| Published Results Link | http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)61168-0/abstract |
| Status | Closed |
| Category | Diverticular Disease |
| Treatment Course | Surgery |
Trial Description
| The first objective (LOLA) of this integrated trial (Ladies) is to determine whether laparoscopic lavage leads to better clinical outcomes compared to sigmoidectomy in patients with perforated diverticulitis with purulent peritonitis in terms of mortality and major morbidity. The study is designed as a multicenter and randomised trial. |
Chief Investigator
|
Willem Bemelman Professor |
| Profile Link |
Lead Centre
|
Academic Medical Centre (AMC), Amsterdam Meibergdreef 9 Amsterdam 1105 Netherlands |
| Website |
Additional Information
Full Research Summary| Objective: | For this two-armed randomised trial two objectives can be defined to determine the optimal strategy for the treatment of perforated diverticulitis. First, is laparoscopic lavage for patients with purulent peritonitis superior compared to sigmoidectomy, in terms of mortality, morbidity, quality of life, health care utilisation and associated costs (LOLA-arm)? Secondly, is HP or PA the superior approach for patients with purulent or faecal generalised peritonitis in terms of stoma free survival, quality of life and cost-effectiveness (DIVA-arm)? |
| Aim: | . |
| Methods: | The Ladies trial is designed as a nationwide multicentre randomised trial in which patients with generalised peritonitis caused by perforated diverticulitis are randomised to undergo either laparoscopic lavage and drainage or resectional surgery by laparotomy. Patients presenting with clinical signs of diverticulitis with diffuse peritonitis can be included upon the finding of free gas on plain abdominal radiography, upon the finding of free gas on CT, or upon the finding of peritonitis with diffuse fluid or gas on CT. Exclusion criteria include dementia, pelvic irradiation, steroid treatment, prior sigmoidectomy and preoperative shock with inotropic requirement. All patients need to fulfil the selection criteria and will need to give written informed consent. Eligible patients undergo diagnostic laparoscopy to exclude other causes of generalised peritonitis. If the diagnosis perforated diverticulitis is confirmed, the patient can be enrolled and randomised. |
| Reason for International Trial: | . |