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PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial

BACKGROUND: Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis, the risk of incisional hernia (IH) is extremely elevated. The evaluation of quality of life of patients with incisional hernia showed lower m...

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Autores principales: Coccolini, F., Tarasconi, A., Petracca, G. L., Perrone, G., Giuffrida, M., Disisto, C., Sartelli, M., Carcoforo, P., Ansaloni, L., Catena, F.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8895107/
https://www.ncbi.nlm.nih.gov/pubmed/35246206
http://dx.doi.org/10.1186/s13063-022-06103-4
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author Coccolini, F.
Tarasconi, A.
Petracca, G. L.
Perrone, G.
Giuffrida, M.
Disisto, C.
Sartelli, M.
Carcoforo, P.
Ansaloni, L.
Catena, F.
author_facet Coccolini, F.
Tarasconi, A.
Petracca, G. L.
Perrone, G.
Giuffrida, M.
Disisto, C.
Sartelli, M.
Carcoforo, P.
Ansaloni, L.
Catena, F.
author_sort Coccolini, F.
collection PubMed
description BACKGROUND: Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis, the risk of incisional hernia (IH) is extremely elevated. The evaluation of quality of life of patients with incisional hernia showed lower mean scores on physical components of health-related quality of life and body image. Furthermore, the arise of a post-operative abdominal wall complication (i.e., wound dehiscence, evisceration and IH) greatly increases morbidity and mortality rates and prolongs the hospitalization. METHODS: The present study aims to evaluate the efficacy of the use of a swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure in urgency/emergency setting against abdominal wall complications in patients operated with contaminated/infected field in peritonitis. The sample size was defined in 90 patients divided in two arms (prosthesis positioning versus normal wall abdominal closure). The follow-up will be performed at 3, 6, and 12 months after surgery. The percentage of incisional hernias, wound infections, and adverse events will be investigated by physical examination and ultrasound. DISCUSSION: The objective is to evaluate the possibility to reduce the incisional hernia rate in patients undergoing urgent/emergent laparotomy in contaminated/infected field with peritonitis by using swine dermal collagen prosthesis preperitoneal positioning as a prophylactic procedure. TRIAL REGISTRATION: ClinicalTrials.gov NCT04681326. Registered (retrospectively after first patient recruited) on 23 December 2020.
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spelling pubmed-88951072022-03-04 PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial Coccolini, F. Tarasconi, A. Petracca, G. L. Perrone, G. Giuffrida, M. Disisto, C. Sartelli, M. Carcoforo, P. Ansaloni, L. Catena, F. Trials Study Protocol BACKGROUND: Patients undergoing emergency surgery for peritonitis are at increased risk of abdominal wall-related complications. In patients with peritonitis, the risk of incisional hernia (IH) is extremely elevated. The evaluation of quality of life of patients with incisional hernia showed lower mean scores on physical components of health-related quality of life and body image. Furthermore, the arise of a post-operative abdominal wall complication (i.e., wound dehiscence, evisceration and IH) greatly increases morbidity and mortality rates and prolongs the hospitalization. METHODS: The present study aims to evaluate the efficacy of the use of a swine dermal collagen prosthesis implanted preperitoneally as a prophylactic procedure in urgency/emergency setting against abdominal wall complications in patients operated with contaminated/infected field in peritonitis. The sample size was defined in 90 patients divided in two arms (prosthesis positioning versus normal wall abdominal closure). The follow-up will be performed at 3, 6, and 12 months after surgery. The percentage of incisional hernias, wound infections, and adverse events will be investigated by physical examination and ultrasound. DISCUSSION: The objective is to evaluate the possibility to reduce the incisional hernia rate in patients undergoing urgent/emergent laparotomy in contaminated/infected field with peritonitis by using swine dermal collagen prosthesis preperitoneal positioning as a prophylactic procedure. TRIAL REGISTRATION: ClinicalTrials.gov NCT04681326. Registered (retrospectively after first patient recruited) on 23 December 2020. BioMed Central 2022-03-04 /pmc/articles/PMC8895107/ /pubmed/35246206 http://dx.doi.org/10.1186/s13063-022-06103-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Coccolini, F.
Tarasconi, A.
Petracca, G. L.
Perrone, G.
Giuffrida, M.
Disisto, C.
Sartelli, M.
Carcoforo, P.
Ansaloni, L.
Catena, F.
PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
title PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
title_full PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
title_fullStr PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
title_full_unstemmed PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
title_short PROPHYlactic Implantation of BIOlogic Mesh in peritonitis (PROPHYBIOM): a prospective multicentric randomized controlled trial
title_sort prophylactic implantation of biologic mesh in peritonitis (prophybiom): a prospective multicentric randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8895107/
https://www.ncbi.nlm.nih.gov/pubmed/35246206
http://dx.doi.org/10.1186/s13063-022-06103-4
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