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:	.

Trial Details

LADIES (DIVA): Laparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Additional Information

Research

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Trial Details

LADIES (DIVA): Laparoscopic peritoneal lavage or resection for generalised peritonitis for perforated diverticulitis: a nationwide multicenter randomised trial (The Ladies Trial).

Trial Overview

Trial Description

Chief Investigator

Lead Centre

Additional Information

Research

About ESCP

News & Events

Education

Research

Members

Contact Us

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