1. 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)
- Author
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Bruin Sjoerd C, Mannaerts Guido HH, Cense Huib A, Blanken-Peeters Charlotte FJM, Neijenhuis Peter A, Karsten Thomas M, Hoofwijk Anton GM, Gerhards Michael F, van Duijn Eino B, Consten Esther CJ, Slooter Gerrit D, Coene Peter-Paul LO, van Wagensveld Bart A, Tollenaar Rob AEM, Stockmann Hein BAC, Prins Hubert A, Pierik Robert EGJM, Weidema Wibo F, de Graaf Eelco JR, Steup Willem H, Swank Dingeman J, Kruyt Philip M, Boom Maarten J, Bosker Robbert JI, Nienhuijs Simon W, Sosef Meindert N, Crolla Rogier MPH, Stassen Laurents PS, van der Hoeven Joost AB, Mulder Irene M, Lange Johan F, Vermeulen Jefrey, Swank Hilko A, 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, and Bemelman Willem A
- Subjects
Surgery ,RD1-811 - Abstract
Abstract 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
- Published
- 2010
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