Browsing by Author "Bouliaris, Konstantinos"
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- ItemOpen Access2020 update of the WSES guidelines for the management of acute colonic diverticulitis in the emergency setting(2020-05-07) Sartelli, Massimo; Weber, Dieter G; Kluger, Yoram; Ansaloni, Luca; Coccolini, Federico; Abu-Zidan, Fikri; Augustin, Goran; Ben-Ishay, Offir; Biffl, Walter L; Bouliaris, Konstantinos; Catena, Rodolfo; Ceresoli, Marco; Chiara, Osvaldo; Chiarugi, Massimo; Coimbra, Raul; Cortese, Francesco; Cui, Yunfeng; Damaskos, Dimitris; de’ Angelis, Gian L; Delibegovic, Samir; Demetrashvili, Zaza; De Simone, Belinda; Di Marzo, Francesco; Di Saverio, Salomone; Duane, Therese M; Faro, Mario P; Fraga, Gustavo P; Gkiokas, George; Gomes, Carlos A; Hardcastle, Timothy C; Hecker, Andreas; Karamarkovic, Aleksandar; Kashuk, Jeffry; Khokha, Vladimir; Kirkpatrick, Andrew W; Kok, Kenneth Y Y; Inaba, Kenji; Isik, Arda; Labricciosa, Francesco M; Latifi, Rifat; Leppäniemi, Ari; Litvin, Andrey; Mazuski, John E; Maier, Ronald V; Marwah, Sanjay; McFarlane, Michael; Moore, Ernest E; Moore, Frederick A; Negoi, Ionut; Pagani, Leonardo; Rasa, Kemal; Rubio-Perez, Ines; Sakakushev, Boris; Sato, Norio; Sganga, Gabriele; Siquini, Walter; Tarasconi, Antonio; Tolonen, Matti; Ulrych, Jan; Zachariah, Sannop K; Catena, FaustoAbstract Acute colonic diverticulitis is one of the most common clinical conditions encountered by surgeons in the acute setting. An international multidisciplinary panel of experts from the World Society of Emergency Surgery (WSES) updated its guidelines for management of acute left-sided colonic diverticulitis (ALCD) according to the most recent available literature. The update includes recent changes introduced in the management of ALCD. The new update has been further integrated with advances in acute right-sided colonic diverticulitis (ARCD) that is more common than ALCD in select regions of the world.
- ItemOpen AccessPhysiological parameters for Prognosis in Abdominal Sepsis (PIPAS) Study: a WSES observational study(2019-07-15) Sartelli, Massimo; Abu-Zidan, Fikri M; Labricciosa, Francesco M; Kluger, Yoram; Coccolini, Federico; Ansaloni, Luca; Leppäniemi, Ari; Kirkpatrick, Andrew W; Tolonen, Matti; Tranà, Cristian; Regimbeau, Jean-Marc; Hardcastle, Timothy; Koshy, Renol M; Abbas, Ashraf; Aday, Ulaş; Adesunkanmi, A. R K; Ajibade, Adesina; Akhmeteli, Lali; Akın, Emrah; Akkapulu, Nezih; Alotaibi, Alhenouf; Altintoprak, Fatih; Anyfantakis, Dimitrios; Atanasov, Boyko; Augustin, Goran; Azevedo, Constança; Bala, Miklosh; Balalis, Dimitrios; Baraket, Oussama; Baral, Suman; Barkai, Or; Beltran, Marcelo; Bini, Roberto; Bouliaris, Konstantinos; Caballero, Ana B; Calu, Valentin; Catani, Marco; Ceresoli, Marco; Charalampakis, Vasileios; Jusoh, Asri C; Chiarugi, Massimo; Cillara, Nicola; Cuesta, Raquel C; Cobuccio, Luigi; Cocorullo, Gianfranco; Colak, Elif; Conti, Luigi; Cui, Yunfeng; De Simone, Belinda; Delibegovic, Samir; Demetrashvili, Zaza; Demetriades, Demetrios; Dimova, Ana; Dogjani, Agron; Enani, Mushira; Farina, Federica; Ferrara, Francesco; Foghetti, Domitilla; Fontana, Tommaso; Fraga, Gustavo P; Gachabayov, Mahir; Gérard, Grelpois; Ghnnam, Wagih; Maurel, Teresa G; Gkiokas, Georgios; Gomes, Carlos A; Guner, Ali; Gupta, Sanjay; Hecker, Andreas; Hirano, Elcio S; Hodonou, Adrien; Hutan, Martin; Ilaschuk, Igor; Ioannidis, Orestis; Isik, Arda; Ivakhov, Georgy; Jain, Sumita; Jokubauskas, Mantas; Karamarkovic, Aleksandar; Kaushik, Robin; Kenig, Jakub; Khokha, Vladimir; Khokha, Denis; Kim, Jae I; Kong, Victor; Korkolis, Dimitris; Kruger, Vitor F; Kshirsagar, Ashok; Simões, Romeo L; Lanaia, Andrea; Lasithiotakis, Konstantinos; Leão, Pedro; Arellano, Miguel L; Listle, Holger; Litvin, Andrey; Lizarazu Pérez, Aintzane; Lopez-Tomassetti Fernandez, Eudaldo; Lostoridis, Eftychios; Luppi, Davide; Machain V, Gustavo M; Major, Piotr; Manatakis, Dimitrios; Reitz, Marianne M; Marinis, Athanasios; Marrelli, Daniele; Martínez-Pérez, Aleix; Marwah, Sanjay; McFarlane, Michael; Mesic, Mirza; Mesina, Cristian; Michalopoulos, Nickos; Misiakos, Evangelos; Moreira, Felipe G; Mouaqit, Ouadii; Muhtaroglu, Ali; Naidoo, Noel; Negoi, Ionut; Nikitina, Zane; Nikolopoulos, Ioannis; Nita, Gabriela-Elisa; Occhionorelli, Savino; Olaoye, Iyiade; Ordoñez, Carlos A; Ozkan, Zeynep; Pal, Ajay; Palini, Gian M; Papageorgiou, Kyriaki; Papagoras, Dimitris; Pata, Francesco; Pędziwiatr, Michał; Pereira, Jorge; Pereira Junior, Gerson A; Perrone, Gennaro; Pintar, Tadeja; Pisarska, Magdalena; Plehutsa, Oleksandr; Podda, Mauro; Poillucci, Gaetano; Quiodettis, Martha; Rahim, Tuba; Rios-Cruz, Daniel; Rodrigues, Gabriel; Rozov, Dmytry; Sakakushev, Boris; Sall, Ibrahima; Sazhin, Alexander; Semião, Miguel; Sharda, Taanya; Shelat, Vishal; Sinibaldi, Giovanni; Skicko, Dmitrijs; Skrovina, Matej; Stamatiou, Dimitrios; Stella, Marco; Strzałka, Marcin; Sydorchuk, Ruslan; Teixeira Gonsaga, Ricardo A; Tochie, Joel N; Tomadze, Gia; Ugoletti, Lara; Ulrych, Jan; Ümarik, Toomas; Uzunoglu, Mustafa Y; Vasilescu, Alin; Vaz, Osborne; Vereczkei, Andras; Vlad, Nutu; Walędziak, Maciej; Yahya, Ali I; Yalkin, Omer; Yilmaz, Tonguç U; Ünal, Ali E; Yuan, Kuo-Ching; Zachariah, Sanoop K; Žilinskas, Justas; Zizzo, Maurizio; Pattonieri, Vittoria; Baiocchi, Gian L; Catena, FaustoAbstract Background Timing and adequacy of peritoneal source control are the most important pillars in the management of patients with acute peritonitis. Therefore, early prognostic evaluation of acute peritonitis is paramount to assess the severity and establish a prompt and appropriate treatment. The objectives of this study were to identify clinical and laboratory predictors for in-hospital mortality in patients with acute peritonitis and to develop a warning score system, based on easily recognizable and assessable variables, globally accepted. Methods This worldwide multicentre observational study included 153 surgical departments across 56 countries over a 4-month study period between February 1, 2018, and May 31, 2018. Results A total of 3137 patients were included, with 1815 (57.9%) men and 1322 (42.1%) women, with a median age of 47 years (interquartile range [IQR] 28–66). The overall in-hospital mortality rate was 8.9%, with a median length of stay of 6 days (IQR 4–10). Using multivariable logistic regression, independent variables associated with in-hospital mortality were identified: age > 80 years, malignancy, severe cardiovascular disease, severe chronic kidney disease, respiratory rate ≥ 22 breaths/min, systolic blood pressure < 100 mmHg, AVPU responsiveness scale (voice and unresponsive), blood oxygen saturation level (SpO2) < 90% in air, platelet count < 50,000 cells/mm3, and lactate > 4 mmol/l. These variables were used to create the PIPAS Severity Score, a bedside early warning score for patients with acute peritonitis. The overall mortality was 2.9% for patients who had scores of 0–1, 22.7% for those who had scores of 2–3, 46.8% for those who had scores of 4–5, and 86.7% for those who have scores of 7–8. Conclusions The simple PIPAS Severity Score can be used on a global level and can help clinicians to identify patients at high risk for treatment failure and mortality.
- ItemOpen AccessThe ChoCO-W prospective observational global study: Does COVID-19 increase gangrenous cholecystitis?(2022-12-16) De Simone, Belinda; Abu-Zidan, Fikri M.; Chouillard, Elie; Di Saverio, Salomone; Sartelli, Massimo; Podda, Mauro; Gomes, Carlos A.; Moore, Ernest E.; Moug, Susan J.; Ansaloni, Luca; Kluger, Yoram; Coccolini, Federico; Landaluce-Olavarria, Aitor; Estraviz-Mateos, Begoña; Uriguen-Etxeberria, Ana; Giordano, Alessio; Luna, Alfonso P.; Amín, Luz A. H.; Hernández, Adriana M. P.; Shabana, Amanda; Dzulkarnaen, Zakaria A.; Othman, Muhammad A.; Sani, Mohamad I.; Balla, Andrea; Scaramuzzo, Rosa; Lepiane, Pasquale; Bottari, Andrea; Staderini, Fabio; Cianchi, Fabio; Cavallaro, Andrea; Zanghì, Antonio; Cappellani, Alessandro; Campagnacci, Roberto; Maurizi, Angela; Martinotti, Mario; Ruggieri, Annamaria; Jusoh, Asri C.; Rahman, Karim A.; Zulkifli, Anis S. M.; Petronio, Barbara; Matías-García, Belén; Quiroga-Valcárcel, Ana; Mendoza-Moreno, Fernando; Atanasov, Boyko; Campanile, Fabio C.; Vecchioni, Ilaria; Cardinali, Luca; Travaglini, Grazia; Sebastiani, Elisa; Chooklin, Serge; Chuklin, Serhii; Cianci, Pasquale; Restini, Enrico; Capuzzolo, Sabino; Currò, Giuseppe; Filippo, Rosalinda; Rispoli, Michele; Aparicio-Sánchez, Daniel; Muñóz-Cruzado, Virginia D.; Barbeito, Sandra D.; Delibegovic, Samir; Kesetovic, Amar; Sasia, Diego; Borghi, Felice; Giraudo, Giorgio; Visconti, Diego; Doria, Emanuele; Santarelli, Mauro; Luppi, Davide; Bonilauri, Stefano; Grossi, Ugo; Zanus, Giacomo; Sartori, Alberto; Piatto, Giacomo; De Luca, Maurizio; Vita, Domenico; Conti, Luigi; Capelli, Patrizio; Cattaneo, Gaetano M.; Marinis, Athanasios; Vederaki, Styliani-Aikaterini; Bayrak, Mehmet; Altıntas, Yasemin; Uzunoglu, Mustafa Y.; Demirbas, Iskender E.; Altinel, Yuksel; Meric, Serhat; Aktimur, Yunus E.; Uymaz, Derya S.; Omarov, Nail; Azamat, Ibrahim; Lostoridis, Eftychios; Nagorni, Eleni-Aikaterini; Pujante, Antonio; Anania, Gabriele; Bombardini, Cristina; Bagolini, Francesco; Gonullu, Emre; Mantoglu, Baris; Capoglu, Recayi; Cappato, Stefano; Muzio, Elena; Colak, Elif; Polat, Suleyman; Koylu, Zehra A.; Altintoprak, Fatih; Bayhan, Zülfü; Akin, Emrah; Andolfi, Enrico; Rezart, Sulce; Kim, Jae I.; Jung, Sung W.; Shin, Yong C.; Enciu, Octavian; Toma, Elena A.; Medas, Fabio; Canu, Gian L.; Cappellacci, Federico; D’Acapito, Fabrizio; Ercolani, Giorgio; Solaini, Leonardo; Roscio, Francesco; Clerici, Federico; Gelmini, Roberta; Serra, Francesco; Rossi, Elena G.; Fleres, Francesco; Clarizia, Guglielmo; Spolini, Alessandro; Ferrara, Francesco; Nita, Gabriela; Sarnari, Jlenia; Gachabayov, Mahir; Abdullaev, Abakar; Poillucci, Gaetano; Palini, Gian M.; Veneroni, Simone; Garulli, Gianluca; Piccoli, Micaela; Pattacini, Gianmaria C.; Pecchini, Francesca; Argenio, Giulio; Armellino, Mariano F.; Brisinda, Giuseppe; Tedesco, Silvia; Fransvea, Pietro; Ietto, Giuseppe; Franchi, Caterina; Carcano, Giulio; Martines, Gennaro; Trigiante, Giuseppe; Negro, Giulia; Vega, Gustavo M.; González, Agustín R.; Ojeda, Leonardo; Piccolo, Gaetano; Bondurri, Andrea; Maffioli, Anna; Guerci, Claudio; Sin, Boo H.; Zuhdi, Zamri; Azman, Azlanudin; Mousa, Hussam; al Bahri, Shadi; Augustin, Goran; Romic, Ivan; Moric, Trpimir; Nikolopoulos, Ioannis; Andreuccetti, Jacopo; Pignata, Giusto; D’Alessio, Rossella; Kenig, Jakub; Skorus, Urszula; Fraga, Gustavo P.; Hirano, Elcio S.; de Lima Bertuol, Jackson V.; Isik, Arda; Kurnaz, Eray; Asghar, Mohammad S.; Afzal, Ameer; Akbar, Ali; Nikolouzakis, Taxiarchis K.; Lasithiotakis, Konstantinos; Chrysos, Emmanuel; Das, Koray; Özer, Nazmi; Seker, Ahmet; Ibrahim, Mohamed; Hamid, Hytham K. S.; Babiker, Ahmed; Bouliaris, Konstantinos; Koukoulis, George; Kolla, Chrysoula-Christina; Lucchi, Andrea; Agostinelli, Laura; Taddei, Antonio; Fortuna, Laura; Agostini, Carlotta; Licari, Leo; Viola, Simona; Callari, Cosimo; Laface, Letizia; Abate, Emmanuele; Casati, Massimiliano; Anastasi, Alessandro; Canonico, Giuseppe; Gabellini, Linda; Tosi, Lorenzo; Guariniello, Anna; Zanzi, Federico; Bains, Lovenish; Sydorchuk, Larysa; Iftoda, Oksana; Sydorchuk, Andrii; Malerba, Michele; Costanzo, Federico; Galleano, Raffaele; Monteleone, Michela; Costanzi, Andrea; Riva, Carlo; Walędziak, Maciej; Kwiatkowski, Andrzej; Czyżykowski, Łukasz; Major, Piotr; Strzałka, Marcin; Matyja, Maciej; Natkaniec, Michal; Valenti, Maria R.; Di Vita, Maria D. P.; Sotiropoulou, Maria; Kapiris, Stylianos; Massalou, Damien; Veroux, Massimiliano; Volpicelli, Alessio; Gioco, Rossella; Uccelli, Matteo; Bonaldi, Marta; Olmi, Stefano; Nardi, Matteo; Livadoti, Giada; Mesina, Cristian; Dumitrescu, Theodor V.; Ciorbagiu, Mihai C.; Ammendola, Michele; Ammerata, Giorgio; Romano, Roberto; Slavchev, Mihail; Misiakos, Evangelos P.; Pikoulis, Emmanouil; Papaconstantinou, Dimitrios; Elbahnasawy, Mohamed; Abdel-elsalam, Sherief; Felsenreich, Daniel M.; Jedamzik, Julia; Michalopoulos, Nikolaos V.; Sidiropoulos, Theodoros A.; Papadoliopoulou, Maria; Cillara, Nicola; Deserra, Antonello; Cannavera, Alessandro; Negoi, Ionuţ; Schizas, Dimitrios; Syllaios, Athanasios; Vagios, Ilias; Gourgiotis, Stavros; Dai, Nick; Gurung, Rekha; Norrey, Marcus; Pesce, Antonio; Feo, Carlo V.; Fabbri, Nicolo’; Machairas, Nikolaos; Dorovinis, Panagiotis; Keramida, Myrto D.; Mulita, Francesk; Verras, Georgios I.; Vailas, Michail; Yalkin, Omer; Iflazoglu, Nidal; Yigit, Direnc; Baraket, Oussama; Ayed, Karim; Ghalloussi, Mohamed h.; Patias, Parmenion; Ntokos, Georgios; Rahim, Razrim; Bala, Miklosh; Kedar, Asaf; Sawyer, Robert G.; Trinh, Anna; Miller, Kelsey; Sydorchuk, Ruslan; Knut, Ruslan; Plehutsa, Oleksandr; Liman, Rumeysa K.; Ozkan, Zeynep; Kader, Saleh A.; Gupta, Sanjay; Gureh, Monika; Saeidi, Sara; Aliakbarian, Mohsen; Dalili, Amin; Shoko, Tomohisa; Kojima, Mitsuaki; Nakamoto, Raira; Atici, Semra D.; Tuncer, Gizem K.; Kaya, Tayfun; Delis, Spiros G.; Rossi, Stefano; Picardi, Biagio; del Monte, Simone R.; Triantafyllou, Tania; Theodorou, Dimitrios; Pintar, Tadeja; Salobir, Jure; Manatakis, Dimitrios K.; Tasis, Nikolaos; Acheimastos, Vasileios; Ioannidis, Orestis; Loutzidou, Lydia; Symeonidis, Savvas; de Sá, Tiago C.; Rocha, Mónica; Guagni, Tommaso; Pantalone, Desiré; Maltinti, Gherardo; Khokha, Vladimir; Abdel-elsalam, Wafaa; Ghoneim, Basma; López-Ruiz, José A.; Kara, Yasin; Zainudin, Syaza; Hayati, Firdaus; Azizan, Nornazirah; Khei, Victoria T. P.; Yi, Rebecca C. X.; Sellappan, Harivinthan; Demetrashvili, Zaza; Lekiashvili, Nika; Tvaladze, Ana; Froiio, Caterina; Bernardi, Daniele; Bonavina, Luigi; Gil-Olarte, Angeles; Grassia, Sebastiano; Romero-Vargas, Estela; Bianco, Francesco; Gumbs, Andrew A.; Dogjani, Agron; Agresta, Ferdinando; Litvin, Andrey; Balogh, Zsolt J.; Gendrikson, George; Martino, Costanza; Damaskos, Dimitrios; Pararas, Nikolaos; Kirkpatrick, Andrew; Kurtenkov, Mikhail; Gomes, Felipe C.; Pisanu, Adolfo; Nardello, Oreste; Gambarini, Fabrizio; Aref, Hager; Angelis, Nicola d.; Agnoletti, Vanni; Biondi, Antonio; Vacante, Marco; Griggio, Giulia; Tutino, Roberta; Massani, Marco; Bisetto, Giovanni; Occhionorelli, Savino; Andreotti, Dario; Lacavalla, Domenico; Biffl, Walter L.; Catena, FaustoAbstract Background The incidence of the highly morbid and potentially lethal gangrenous cholecystitis was reportedly increased during the COVID-19 pandemic. The aim of the ChoCO-W study was to compare the clinical findings and outcomes of acute cholecystitis in patients who had COVID-19 disease with those who did not. Methods Data were prospectively collected over 6 months (October 1, 2020, to April 30, 2021) with 1-month follow-up. In October 2020, Delta variant of SARS CoV-2 was isolated for the first time. Demographic and clinical data were analyzed and reported according to the STROBE guidelines. Baseline characteristics and clinical outcomes of patients who had COVID-19 were compared with those who did not. Results A total of 2893 patients, from 42 countries, 218 centers, involved, with a median age of 61.3 (SD: 17.39) years were prospectively enrolled in this study; 1481 (51%) patients were males. One hundred and eighty (6.9%) patients were COVID-19 positive, while 2412 (93.1%) were negative. Concomitant preexisting diseases including cardiovascular diseases (p < 0.0001), diabetes (p < 0.0001), and severe chronic obstructive airway disease (p = 0.005) were significantly more frequent in the COVID-19 group. Markers of sepsis severity including ARDS (p < 0.0001), PIPAS score (p < 0.0001), WSES sepsis score (p < 0.0001), qSOFA (p < 0.0001), and Tokyo classification of severity of acute cholecystitis (p < 0.0001) were significantly higher in the COVID-19 group. The COVID-19 group had significantly higher postoperative complications (32.2% compared with 11.7%, p < 0.0001), longer mean hospital stay (13.21 compared with 6.51 days, p < 0.0001), and mortality rate (13.4% compared with 1.7%, p < 0.0001). The incidence of gangrenous cholecystitis was doubled in the COVID-19 group (40.7% compared with 22.3%). The mean wall thickness of the gallbladder was significantly higher in the COVID-19 group [6.32 (SD: 2.44) mm compared with 5.4 (SD: 3.45) mm; p < 0.0001]. Conclusions The incidence of gangrenous cholecystitis is higher in COVID patients compared with non-COVID patients admitted to the emergency department with acute cholecystitis. Gangrenous cholecystitis in COVID patients is associated with high-grade Clavien-Dindo postoperative complications, longer hospital stay and higher mortality rate. The open cholecystectomy rate is higher in COVID compared with non -COVID patients. It is recommended to delay the surgical treatment in COVID patients, when it is possible, to decrease morbidity and mortality rates. COVID-19 infection and gangrenous cholecystistis are not absolute contraindications to perform laparoscopic cholecystectomy, in a case by case evaluation, in expert hands. Graphical abstract
- ItemOpen AccessThe unrestricted global effort to complete the COOL trial(2023-05-11) 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. M.; 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 A.; 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 A.; Aranda-Narváez, José M.; Baraket, Oussama; Biffl, Walter L.; Baiocchi, Gian L.; 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 F.; Huei, Tan J.; Jailani, Ruhi F.; Khan, Mansoor; Luna, Alfonso P.; Malbrain, Manu L. N. G.; Marwah, Sanjay; McBeth, Paul; Mihailescu, Andrei; Morello, Alessia; Mulita, Francesk; Murzi, Valentina; Mohammad, Ahmad T.; Parmar, Simran; Pak, Ajay; Wong, Michael P.; 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 A. G.; Waledziak, Maciej; Xenaki, Sofia; Winter, Desmond; Wu, Xiuwen; Zakaria, Andee D.; Zakaria, ZaidiAbstract 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. Trial registration: National Institutes of Health ( https://clinicaltrials.gov/ct2/show/NCT03163095 ).