The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037).

Christophe Remue,Willem A. Bemelman ,Maarten J. Boom ,Hubert A. Prins ,Huib A. Cense ,Peter A. Neijenhuis ,Marinus J. Wiezer ,Irene M. Mulder ,Donald L. Van Der Peet ,Philip M. Kruyt ,G. H. H. Mannaerts ,Eino B van Duijn,Dingeman J. Swank ,Rogier M. P. H. Crolla ,Sjoerd C. Bruin ,Eric J. Hazebroek ,Robbert J. I. Bosker ,Gerrit D. Slooter ,Thomas Karsten ,W. F. Weidema ,John K. Maring ,Alex Kartheuser,Robert Pierik ,C.f.j.m. Blanken-Peeters ,Laurents P. S. Stassen ,Michael F. Gerhards ,Marc J. P. M. Govaert ,Rob A.e.m. Tollenaar ,Hilko A Swank,J. Konsten ,A. G. M. Hoofwijk ,Alexander Engel ,Q. A. J. Eijsbouts ,Johan F. Lange ,Helma MU van Grevenstein,Peter-Paul Coene ,Jefrey Vermeulen,Johannes B. Reitsma ,Esther C. J. Consten ,J. A. Van Der Hoeven ,Bart A. Van Wagensveld ,André D’hoore ,Eelco J. De Graaf ,Anna AW van Geloven,Simon W. Nienhuijs ,Meindert N. Sosef ,W. H. Steup ,H. B. A. C. Stockmann

doi:10.1186/1471-2482-10-29

Abstract

BackgroundRecently, 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/DesignIn 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.DiscussionThe 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 registrationNederlands Trial Register NTR2037

Highlights

Excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy
Methods/Design 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
Since the introduction of laparoscopic lavage and drainage for purulent peritonitis for perforated diverticulitis in 1996, the number of patients treated with this new method had gradually inclined

Summary

Introduction

Excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy. Diverticular disease is an important condition in terms of healthcare utilisation and it is one of the five most costly gastrointestinal disorders in westernised countries [1] Despite this high prevalence, treatment of all different stages of diverticular disease is still hardly evidence based, containing a lot of controversies. Perforated diverticulitis is a perforation of an inflamed diverticulum of the large bowel, mostly the sigmoid, resulting in either purulent or faecal peritonitis (Hinchey stadia III or IV). Both conditions require emergency surgery[2,3]. Stoma reversal after HP is only performed in 50 to 60% of the patients, thereby compromising quality of life and increasing costs[13,14]

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