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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).
BMC Surg. 2010 Oct 18; 10:29.BS

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.

Authors+Show Affiliations

Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20955571

Citation

Swank, Hilko A., et al. "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)." BMC Surgery, vol. 10, 2010, p. 29.
Swank HA, Vermeulen J, Lange JF, et al. 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). BMC Surg. 2010;10:29.
Swank, H. A., Vermeulen, J., Lange, J. F., Mulder, I. M., van der Hoeven, J. A., Stassen, L. P., Crolla, R. M., Sosef, M. N., Nienhuijs, S. W., Bosker, R. J., Boom, M. J., Kruyt, P. M., Swank, D. J., Steup, W. H., de Graaf, E. J., Weidema, W. F., Pierik, R. E., Prins, H. A., Stockmann, H. B., ... Bemelman, W. A. (2010). 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). BMC Surgery, 10, 29. https://doi.org/10.1186/1471-2482-10-29
Swank HA, et al. 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). BMC Surg. 2010 Oct 18;10:29. PubMed PMID: 20955571.
* Article titles in AMA citation format should be in sentence-case
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 J R, AU - Weidema,Wibo F, AU - Pierik,Robert E G J M, AU - Prins,Hubert A, AU - Stockmann,Hein 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 Duijn,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,André J L, AU - Kartheuser,Alex, AU - Remue,Christophe, AU - van Grevenstein,Helma 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 - ,, Y1 - 2010/10/18/ PY - 2010/09/06/received PY - 2010/10/18/accepted PY - 2010/10/20/entrez PY - 2010/10/20/pubmed PY - 2011/3/16/medline SP - 29 EP - 29 JF - BMC surgery JO - BMC Surg VL - 10 N2 - 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. SN - 1471-2482 UR - https://www.unboundmedicine.com/medline/citation/20955571/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__ L2 - https://bmcsurg.biomedcentral.com/articles/10.1186/1471-2482-10-29 DB - PRIME DP - Unbound Medicine ER -