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 diverticulitis (NTR2037)
Authors: Swank Hilko A , Vermeulen Jefrey , Lange Johan F , Mulder Irene M , van der Hoeven Joost AB , Stassen Laurents PS , Crolla Rogier MPH , Sosef Meindert N , Nienhuijs Simon W , Bosker Robbert JI , Boom Maarten J , Kruyt Philip M , Swank Dingeman J , Steup Willem H , de Graaf Eelco JR , Weidema Wibo F , Pierik Robert EGJM , Prins Hubert A , Stockmann Hein BAC , Tollenaar Rob AEM , van Wagensveld Bart A , Coene Peter-Paul LO , Slooter Gerrit D , Consten Esther CJ , van Duijn Eino B , Gerhards Michael F , Hoofwijk Anton GM , Karsten Thomas M , Neijenhuis Peter A , Blanken-Peeters Charlotte FJM , Cense Huib A , Mannaerts Guido HH , Bruin Sjoerd C , Eijsbouts Quirijn AJ , Wiezer Marinus J , Hazebroek Eric J , van Geloven Anna AW , Maring John K , D'Hoore André JL , Kartheuser Alex , Remue Christophe , van Grevenstein Helma MU , Konsten Joop LM , van der Peet Donald L , Govaert Marc JPM , Engel Alexander F , Reitsma Johannes B , Bemelman Willem A ,   Dutch Diverticular Disease (3D) Collaborative Study Group
Published: November 2010

Background

Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.

The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis).

Methods/Design

In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.

Discussion

The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.

Trial registration

Nederlands Trial Register NTR2037