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The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037)
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 p...
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| Formato: | Texto |
| Lenguaje: | English |
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BioMed Central
2010
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2974662/ https://www.ncbi.nlm.nih.gov/pubmed/20955571 http://dx.doi.org/10.1186/1471-2482-10-29 |
| _version_ | 1782190886494404608 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Swank, Hilko A |
| collection | PubMed |
| description | 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 |
| format | Text |
| id | pubmed-2974662 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2010 |
| publisher | BioMed Central |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-29746622010-11-06 The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) 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 BMC Surg Study Protocol 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 BioMed Central 2010-10-18 /pmc/articles/PMC2974662/ /pubmed/20955571 http://dx.doi.org/10.1186/1471-2482-10-29 Text en Copyright ©2010 Swank et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
| spellingShingle | Study Protocol 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 The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) |
| title | The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) |
| title_full | The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) |
| title_fullStr | The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) |
| title_full_unstemmed | The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) |
| title_short | The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(A )and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(B )in perforated diverticulitis (NTR2037) |
| title_sort | ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis(a )and hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis(b )in perforated diverticulitis (ntr2037) |
| topic | Study Protocol |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2974662/ https://www.ncbi.nlm.nih.gov/pubmed/20955571 http://dx.doi.org/10.1186/1471-2482-10-29 |
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ladiestriallaparoscopicperitoneallavageorresectionforpurulentperitonitisaandhartmannsprocedureorresectionwithprimaryanastomosisforpurulentorfaecalperitonitisbinperforateddiverticulitisntr2037 AT vangrevensteinhelmamu ladiestriallaparoscopicperitoneallavageorresectionforpurulentperitonitisaandhartmannsprocedureorresectionwithprimaryanastomosisforpurulentorfaecalperitonitisbinperforateddiverticulitisntr2037 AT konstenjooplm ladiestriallaparoscopicperitoneallavageorresectionforpurulentperitonitisaandhartmannsprocedureorresectionwithprimaryanastomosisforpurulentorfaecalperitonitisbinperforateddiverticulitisntr2037 AT vanderpeetdonaldl ladiestriallaparoscopicperitoneallavageorresectionforpurulentperitonitisaandhartmannsprocedureorresectionwithprimaryanastomosisforpurulentorfaecalperitonitisbinperforateddiverticulitisntr2037 AT govaertmarcjpm 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