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Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol

BACKGROUND: Peritoneal dialysis (PD) is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outf...

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Autores principales: Hagen, Sander M, van Alphen, Arjan M, IJzermans, Jan NM, Dor, Frank JMF
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266194/
https://www.ncbi.nlm.nih.gov/pubmed/22185091
http://dx.doi.org/10.1186/1471-2482-11-35
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author Hagen, Sander M
van Alphen, Arjan M
IJzermans, Jan NM
Dor, Frank JMF
author_facet Hagen, Sander M
van Alphen, Arjan M
IJzermans, Jan NM
Dor, Frank JMF
author_sort Hagen, Sander M
collection PubMed
description BACKGROUND: Peritoneal dialysis (PD) is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking. METHODS/DESIGN: The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot). The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques. DISCUSSION: This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion. TRIAL REGISTRATION: Dutch Trial Register NTR2878
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spelling pubmed-32661942012-01-26 Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol Hagen, Sander M van Alphen, Arjan M IJzermans, Jan NM Dor, Frank JMF BMC Surg Study Protocol BACKGROUND: Peritoneal dialysis (PD) is an effective treatment for end-stage renal disease. It allows patients more freedom to perform daily activities compared to haemodialysis. Key to successful PD is the presence of a well-functioning dialysis catheter. Several complications, such as in- and outflow obstruction, peritonitis, exit-site infections, leakage and migration, can lead to catheter removal and loss of peritoneal access. Currently, different surgical techniques are in practice for PD-catheter placement. The type of insertion technique used may greatly influence the occurrence of complications. In the literature, up to 35% catheter failure has been described when using the open technique and only 13% for the laparoscopic technique. However, a well-designed randomized controlled trial is lacking. METHODS/DESIGN: The LOCI-trial is a multi-center randomized controlled, single-blind trial (pilot). The study compares the laparoscopic with the open technique for PD catheter insertion. The primary objective is to determine the optimum placement technique in order to minimize the incidence of catheter malfunction at 6 weeks postoperatively. Secondary objectives are to determine the best approach to optimize catheter function and to study the quality of life at 6 months postoperatively comparing the two operative techniques. DISCUSSION: This study will generate evidence on any benefits of laparoscopic versus open PD catheter insertion. TRIAL REGISTRATION: Dutch Trial Register NTR2878 BioMed Central 2011-12-20 /pmc/articles/PMC3266194/ /pubmed/22185091 http://dx.doi.org/10.1186/1471-2482-11-35 Text en Copyright ©2011 Hagen 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
Hagen, Sander M
van Alphen, Arjan M
IJzermans, Jan NM
Dor, Frank JMF
Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol
title Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol
title_full Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol
title_fullStr Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol
title_full_unstemmed Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol
title_short Laparoscopic versus open peritoneal dialysis catheter insertion, the LOCI-trial: a study protocol
title_sort laparoscopic versus open peritoneal dialysis catheter insertion, the loci-trial: a study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3266194/
https://www.ncbi.nlm.nih.gov/pubmed/22185091
http://dx.doi.org/10.1186/1471-2482-11-35
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