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The unrestricted global effort to complete the COOL trial
World Journal of Emergency Surgery, 18 (2023), 1; 33. https://doi.org/10.1186/s13017-023-00500-z
Kirkpatrick, Andrew W.; Coccolini, Federico; Tolonen, Matti; Minor, Samuel; Catena, Fausto; Gois, Emanuel; Doig, Christopher J.; Hill, Michael D.; Ansaloni, Luca; Chiarugi, Massimo; Tartaglia, Dario; Ioannidis, Orestis; Sugrue, Michael; Colak, Elif; Hameed, S. Morad; Lampela, Hanna; Agnoletti, Vanni; McKee, Jessica L.; Garraway, Naisan; Sartelli, Massimo; Ball, Chad G.; Parry, Neil G.; Voght, Kelly; Julien, Lisa; Kroeker, Jenna; Roberts, Derek J.; Faris, Peter; Tiruta, Corina; Moore, Ernest E.; Ammons, Lee Anne; Anestiadou, Elissavet; Bendinelli, Cino; Bouliaris, Konstantinos; Carroll, Rosemarry; Ceresoli, Marco; Favi, Francesco; Gurrado, Angela; Rezende-Neto, Joao; Isik, Arda; Cremonini, Camilla; Strambi, Silivia; Koukoulis, Georgios; Testini, Mario; Trpcic, Sandy; Pasculli, Alessandro; Picariello, Erika; Abu-Zidan, Fikri; Adeyeye, Ademola; Augustin, Goran; Alconchel, Felipe; Altinel, Yuksel; Hernandez Amin, Luz Adriana; Aranda-Narváez, José Manuel; Baraket, Oussama; Biffl, Walter L.; Baiocchi, Gian Luca; Bonavina, Luigi; Brisinda, Giuseppe; Cardinali, Luca; Celotti, Andrea; Chaouch, Mohamed; Chiarello, Maria; Costa, Gianluca; de’Angelis, Nicola; De Manzini, Nicolo; Delibegovic, Samir; Di Saverio, Salomone; De Simone, Belinda; Dubuisson, Vincent; Fransvea, Pietro; Garulli, Gianluca; Giordano, Alessio; Gomes, Carlos; Hayati, Firdaus; Huang, Jinjian; Ibrahim, Aini Fahriza; Huei, Tan Jih; Jailani, Ruhi Fadzlyana; Khan, Mansoor; Luna, Alfonso Palmieri; Malbrain, Manu L. N. G.; Marwah, Sanjay; McBeth, Paul; Mihailescu, Andrei; Morello, Alessia; Mulita, Francesk; Murzi, Valentina; Mohammad, Ahmad Tarmizi; Parmar, Simran; Pak, Ajay; Wong, Michael Pak-Kai; Pantalone, Desire; Podda, Mauro; Puccioni, Caterina; Rasa, Kemal; Ren, Jianan; Roscio, Francesco; Gonzalez-Sanchez, Antonio; Sganga, Gabriele; Scheiterle, Maximilian; Slavchev, Mihail; Smirnov, Dmitry; Tosi, Lorenzo; Trivedi, Anand; Vega, Jaime Andres Gonzalez; Waledziak, Maciej; Xenaki, Sofia; Winter, Desmond; Wu, Xiuwen; Zakaria, Andee Dzulkarnean; Zakaria, Zaidi Više autora...

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Kirkpatrick, A. W., Coccolini, F., Tolonen, M., Minor, S., Catena, F., Gois, E. ... Zakaria, Z. (2023). The unrestricted global effort to complete the COOL trial. World Journal of Emergency Surgery, 18. (1). doi: 10.1186/s13017-023-00500-z

Kirkpatrick, Andrew W., et al. "The unrestricted global effort to complete the COOL trial." World Journal of Emergency Surgery, vol. 18, br. 1, 2023. https://doi.org/10.1186/s13017-023-00500-z

Kirkpatrick, Andrew W., Federico Coccolini, Matti Tolonen, Samuel Minor, Fausto Catena, Emanuel Gois, Christopher J. Doig, et al. "The unrestricted global effort to complete the COOL trial." World Journal of Emergency Surgery 18, br. 1 (2023). https://doi.org/10.1186/s13017-023-00500-z

Kirkpatrick, A. W., et al. (2023) 'The unrestricted global effort to complete the COOL trial', World Journal of Emergency Surgery, 18(1). doi: 10.1186/s13017-023-00500-z

Kirkpatrick AW, Coccolini F, Tolonen M, Minor S, Catena F, Gois E, i sur.. The unrestricted global effort to complete the COOL trial. World Journal of Emergency Surgery [Internet]. 11.05.2023. [pristupljeno 08.10.2024.];18(1). doi: 10.1186/s13017-023-00500-z

A. W. Kirkpatrick, et al., "The unrestricted global effort to complete the COOL trial", World Journal of Emergency Surgery, vol. 18, br. 1, Svibanj 2023. [Online]. Dostupno na: https://urn.nsk.hr/urn:nbn:hr:105:105136. [Citirano: 08.10.2024.]

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Naslov (engleski)The unrestricted global effort to complete the COOL trial
AutorAndrew W. Kirkpatrick
AutorFederico Coccolini
AutorMatti Tolonen
AutorSamuel Minor
AutorFausto Catena
AutorEmanuel Gois
AutorChristopher J. Doig
AutorMichael D. Hill
AutorLuca Ansaloni
AutorMassimo Chiarugi
AutorDario Tartaglia
AutorOrestis Ioannidis
AutorMichael Sugrue
AutorElif Colak
AutorS. Morad Hameed
AutorHanna Lampela
AutorVanni Agnoletti
AutorJessica L. McKee
AutorNaisan Garraway
AutorMassimo Sartelli
AutorChad G. Ball
AutorNeil G. Parry
AutorKelly Voght
AutorLisa Julien
AutorJenna Kroeker
AutorDerek J. Roberts
AutorPeter Faris
AutorCorina Tiruta
AutorErnest E. Moore
AutorLee Anne Ammons
AutorElissavet Anestiadou
AutorCino Bendinelli
AutorKonstantinos Bouliaris
AutorRosemarry Carroll
AutorMarco Ceresoli
AutorFrancesco Favi
AutorAngela Gurrado
AutorJoao Rezende-Neto
AutorArda Isik
AutorCamilla Cremonini
AutorSilivia Strambi
AutorGeorgios Koukoulis
AutorMario Testini
AutorSandy Trpcic
AutorAlessandro Pasculli
AutorErika Picariello
AutorFikri Abu-Zidan
AutorAdemola Adeyeye
AutorGoran Augustin
AutorFelipe Alconchel
AutorYuksel Altinel
AutorLuz Adriana Hernandez Amin
AutorJosé Manuel Aranda-Narváez
AutorOussama Baraket
AutorWalter L. Biffl
AutorGian Luca Baiocchi
AutorLuigi Bonavina
AutorGiuseppe Brisinda
AutorLuca Cardinali
AutorAndrea Celotti
AutorMohamed Chaouch
AutorMaria Chiarello
AutorGianluca Costa
AutorNicola de’Angelis
AutorNicolo De Manzini
AutorSamir Delibegovic
AutorSalomone Di Saverio
AutorBelinda De Simone
AutorVincent Dubuisson
AutorPietro Fransvea
AutorGianluca Garulli
AutorAlessio Giordano
AutorCarlos Gomes
AutorFirdaus Hayati
AutorJinjian Huang
AutorAini Fahriza Ibrahim
AutorTan Jih Huei
AutorRuhi Fadzlyana Jailani
AutorMansoor Khan
AutorAlfonso Palmieri Luna
AutorManu L. N. G. Malbrain
AutorSanjay Marwah
AutorPaul McBeth
AutorAndrei Mihailescu
AutorAlessia Morello
AutorFrancesk Mulita
AutorValentina Murzi
AutorAhmad Tarmizi Mohammad
AutorSimran Parmar
AutorAjay Pak
AutorMichael Pak-Kai Wong
AutorDesire Pantalone
AutorMauro Podda
AutorCaterina Puccioni
AutorKemal Rasa
AutorJianan Ren
AutorFrancesco Roscio
AutorAntonio Gonzalez-Sanchez
AutorGabriele Sganga
AutorMaximilian Scheiterle
AutorMihail Slavchev
AutorDmitry Smirnov
AutorLorenzo Tosi
AutorAnand Trivedi
AutorJaime Andres Gonzalez Vega
AutorMaciej Waledziak
AutorSofia Xenaki
AutorDesmond Winter
AutorXiuwen Wu
AutorAndee Dzulkarnean Zakaria
AutorZaidi Zakaria
Autorova ustanovaSveučilište u Zagrebu
Medicinski fakultet
(KATEDRA ZA KIRURGIJU)
Znanstveno / umjetničko
područje, polje i grana		BIOMEDICINA I ZDRAVSTVO
Kliničke medicinske znanosti
Kirurgija
Sažetak (engleski)
Background: Severe complicated intra-abdominal sepsis (SCIAS) has an increasing incidence with mortality rates over 80% in some settings. Mortality typically results from disruption of the gastrointestinal tract, progressive and self-perpetuating bio-mediator generation, systemic inflammation, and multiple organ failure. A further therapeutic option may be open abdomen (OA) management with negative peritoneal pressure therapy (NPPT) to remove inflammatory ascites and attenuate the systemic damage from SCIAS, although there are definite risks of leaving the abdomen open whenever it might possibly be closed. This potential therapeutic paradigm is the rationale being assessed in the Closed Or Open after Laparotomy (COOL trial) ( https://clinicaltrials.gov/ct2/show/NCT03163095 ). Initially, the COOL trial received Industry sponsorship; however, this funding mandated the use of a specific trademarked and expensive NPPT device in half of the patients allocated to the intervention (open) arm. In August 2022, the 3 M/Acelity Corporation without consultation but within the terms of the contract canceled the financial support of the trial. Although creating financial difficulty, there is now no restriction on specific NPPT devices and removing a cost-prohibitive intervention creates an opportunity to expand the COOL trial to a truly global basis. This document describes the evolution of the COOL trial, with a focus on future opportunities for global growth of the study. Methods: The COOL trial is the largest prospective randomized controlled trial examining the random allocation of SCIAS patients intra-operatively to either formal closure of the fascia or the use of the OA with an application of an NPPT dressing. Patients are eligible if they have free uncontained intraperitoneal contamination and physiologic derangements exemplified by septic shock OR severely adverse predicted clinical outcomes. The primary outcome is intended to definitively inform global practice by conclusively evaluating 90-day survival. Initial recruitment has been lower than hoped but satisfactory, and the COOL steering committee and trial investigators intend with increased global support to continue enrollment until recruitment ensures a definitive answer. Discussion: OA is mandated in many cases of SCIAS such as the risk of abdominal compartment syndrome associated with closure, or a planned second look as for example part of "damage control"; however, improved source control (locally and systemically) is the most uncertain indication for an OA. The COOL trial seeks to expand potential sites and proceed with the evaluation of NPPT agnostic to device, to properly examine the hypothesis that this treatment attenuates systemic damage and improves survival. This approach will not affect internal validity and should improve the external validity of any observed results of the intervention.
Ključne riječi (engleski)
Jezikengleski
Vrsta publikacijeZnanstveni rad - Izvorni znanstveni rad
Status objaveObjavljen
Vrsta recenzijeRecenziran
Verzija publikacijeObjavljena verzija rada (izdavačev PDF)
Naslov časopisaWorld Journal of Emergency Surgery
Brojčani podacivol. 18, br. 1, 33
e-ISSN1749-7922
DOIhttps://doi.org/10.1186/s13017-023-00500-z
URN:NBNurn:nbn:hr:105:105136
Datum objave publikacije2023-05-11
URL dokumentahttps://wjes.biomedcentral.com/articles/10.1186/s13017-023-00500-z
Vrsta resursaTekst
Prava pristupaOtvoreni pristup
Uvjeti korištenjaIkona licence Imenovanje 4.0 međunarodna (CC BY 4.0)
Datum i vrijeme pohrane2023-11-02 09:38:51