TY - JOUR
T1 - 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)
AU - Swank, Hilko A.
AU - Vermeulen, Jefrey
AU - Lange, Johan F.
AU - Mulder, Irene M.
AU - van der Hoeven, Joost A. B.
AU - Stassen, Laurents P. S.
AU - Crolla, Rogier M. P. H.
AU - Sosef, Meindert N.
AU - Nienhuijs, Simon W.
AU - Bosker, Robbert J. I.
AU - Boom, Maarten J.
AU - Kruyt, Philip M.
AU - Swank, Dingeman J.
AU - Steup, Willem H.
AU - de Graaf, Eelco Jr
AU - Weidema, Wibo F.
AU - Pierik, Robert E. G. J. M.
AU - Prins, Hubert A.
AU - Stockmann, Henricus B. A. C.
AU - Tollenaar, Rob A. E. M.
AU - van Wagensveld, Bart A.
AU - Coene, Peter-Paul L. O.
AU - Slooter, Gerrit D.
AU - Consten, Esther C. J.
AU - van Duyn, Eino B.
AU - Gerhards, Michael F.
AU - Hoofwijk, Anton G. M.
AU - Karsten, Thomas M.
AU - Neijenhuis, Peter A.
AU - Blanken-Peeters, Charlotte F. J. M.
AU - Cense, Huib A.
AU - Mannaerts, Guido H. H.
AU - Bruin, Sjoerd C.
AU - Eijsbouts, Quirijn A. J.
AU - Wiezer, Marinus J.
AU - Hazebroek, Eric J.
AU - van Geloven, Anna A. W.
AU - Maring, John K.
AU - D'Hoore, Andre
AU - Kartheuser, Alex
AU - Remue, Christophe
AU - van Grevenstein, Wilhelmina M. U.
AU - Konsten, Joop L. M.
AU - van der Peet, Donald L.
AU - Govaert, Marc J. P. M.
AU - Engel, Alexander F.
AU - Reitsma, Johannes B.
AU - Bemelman, Willem A.
AU - 3d, The Dutch Diverticular Disease Collaborative Study Group
PY - 2010
Y1 - 2010
N2 - 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 with or without Anastomosis). 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
AB - 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 with or without Anastomosis). 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
U2 - https://doi.org/10.1186/1471-2482-10-29
DO - https://doi.org/10.1186/1471-2482-10-29
M3 - Article
C2 - 20955571
SN - 1471-2482
VL - 10
SP - 29
JO - BMC Surgery
JF - BMC Surgery
IS - 1
ER -