Randomized Controlled Trial

. 2023 May 11;18(1):33.

doi: 10.1186/s13017-023-00500-z.

The unrestricted global effort to complete the COOL trial

Andrew W Kirkpatrick¹, Federico Coccolini², Matti Tolonen³, Samuel Minor⁴, Fausto Catena⁵, Emanuel Gois Jr⁶, Christopher J Doig⁷, Michael D Hill⁸, Luca Ansaloni⁹, Massimo Chiarugi¹⁰, Dario Tartaglia¹⁰, Orestis Ioannidis¹¹, Michael Sugrue¹², Elif Colak¹³, S Morad Hameed¹⁴, Hanna Lampela¹⁵, Vanni Agnoletti¹⁶, Jessica L McKee¹⁷, Naisan Garraway¹⁸, Massimo Sartelli¹⁹, Chad G Ball²⁰, Neil G Parry²¹, Kelly Voght²¹, Lisa Julien²², Jenna Kroeker¹⁸, Derek J Roberts²³, Peter Faris²⁴, Corina Tiruta²⁵, Ernest E Moore²⁶, Lee Anne Ammons²⁷, Elissavet Anestiadou¹¹, Cino Bendinelli²⁸, Konstantinos Bouliaris²⁹, Rosemarry Carroll²⁸, Marco Ceresoli³⁰, Francesco Favi³¹, Angela Gurrado³², Joao Rezende-Neto³³, Arda Isik³⁴, Camilla Cremonini¹⁰, Silivia Strambi¹⁰, Georgios Koukoulis²⁹, Mario Testini³², Sandy Trpcic³³, Alessandro Pasculli³², Erika Picariello³⁵, Fikri Abu-Zidan³⁶, Ademola Adeyeye³⁷, Goran Augustin³⁸, Felipe Alconchel³⁹, Yuksel Altinel⁴⁰, Luz Adriana Hernandez Amin⁴¹, José Manuel Aranda-Narváez⁴², Oussama Baraket⁴³, Walter L Biffl⁴⁴, Gian Luca Baiocchi⁴⁵, Luigi Bonavina⁴⁶, Giuseppe Brisinda⁴⁷, Luca Cardinali⁴⁸, Andrea Celotti⁴⁹, Mohamed Chaouch⁵⁰, Maria Chiarello⁵¹, Gianluca Costa⁵², Nicola de'Angelis⁵³, Nicolo De Manzini⁵⁴, Samir Delibegovic⁵⁵, Salomone Di Saverio⁵⁶, Belinda De Simone^{57

58}, Vincent Dubuisson⁵⁹, Pietro Fransvea⁶⁰, Gianluca Garulli⁶¹, Alessio Giordano⁶², Carlos Gomes⁶³, Firdaus Hayati⁶⁴, Jinjian Huang⁶⁵, Aini Fahriza Ibrahim⁶⁶, Tan Jih Huei⁶⁷, Ruhi Fadzlyana Jailani⁶⁸, Mansoor Khan⁶⁹, Alfonso Palmieri Luna⁷⁰, Manu L N G Malbrain^{71

72}, Sanjay Marwah⁷³, Paul McBeth⁷⁴, Andrei Mihailescu⁷⁵, Alessia Morello⁷⁶, Francesk Mulita⁷⁷, Valentina Murzi⁷⁸, Ahmad Tarmizi Mohammad⁷⁹, Simran Parmar²⁴, Ajay Pak⁸⁰, Michael Pak-Kai Wong⁸¹, Desire Pantalone⁸², Mauro Podda⁸³, Caterina Puccioni⁸⁴, Kemal Rasa⁸⁵, Jianan Ren⁶⁵, Francesco Roscio⁸⁶, Antonio Gonzalez-Sanchez⁴², Gabriele Sganga⁸⁴, Maximilian Scheiterle⁸⁷, Mihail Slavchev⁸⁸, Dmitry Smirnov⁸⁹, Lorenzo Tosi⁹⁰, Anand Trivedi⁹¹, Jaime Andres Gonzalez Vega⁹², Maciej Waledziak⁹³, Sofia Xenaki⁹⁴, Desmond Winter⁹⁵, Xiuwen Wu⁶⁵, Andee Dzulkarnean Zakaria⁹⁶, Zaidi Zakaria⁹⁶

Affiliations

¹ Departments of Surgery and Critical Care Medicine, University of Calgary, Foothills Medical Centre, Calgary, AB, EG23T2N 2T9, Canada. Andrew.kirkpatrick@albertahealthservices.ca.
² General, Emergency and Trauma Surgery Department, Pisa University Hospital, Pisa, Italy.
³ Abdominal Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
⁴ Departments of Critical Care Medicine and Surgery, Dalhousie University, Halifax, NS, Canada.
⁵ Department of Surgery, Bufalini Hospital, Cesena, Italy.
⁶ Department of Surgery, Londrina State University, and National COOL Coordinator for Brazil, Londrina, Brazil.
⁷ Departments of Critical Care Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
⁸ Department of Clinical Neuroscience and Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary and Foothills Medical Centre, Calgary, AB, Canada.
⁹ General Surgery I, San Matteo Hospital Pavia, University of Pavia, Pavia, Italy.
¹⁰ Emergency Surgery and Trauma Center, University of Pisa, Pisa, Italy.
¹¹ 4th Department of Surgery, Medical School, Aristotle University of Thessaloniki, General Hospital "George Papanikolaou", Thessaloniki, Greece.
¹² Letterkenny University Hospital, Donegal, Ireland.
¹³ University of Samsun, Samsun Training and Research Hospital, Samsun, Turkey.
¹⁴ Department of Surgery, University of British Columbia, Vancouver, BC, Canada.
¹⁵ Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Espoo, Finland.
¹⁶ Chief Anesthesiology, Bufalini Hospital, Cesena, Italy.
¹⁷ Global Project Manager, COOL Trial and the TeleMentored Ultrasound Supported Medical Interventions Research Group, Calgary, AB, Canada.
¹⁸ Departments of Surgery and Critical Care Medicine, University of British Columbia, Vancouver, BC, Canada.
¹⁹ Department of Surgery, Macerata Hospital, Global Alliance for Infections in Surgery, Macerata, Italy.
²⁰ Trauma and Acute Care Surgery, Foothills Medical Center, Calgary, AB, Canada.
²¹ Departments of Surgery and Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
²² Department of Surgery, NSHA-Queen Elizabeth II Health Sciences Center, Dalhousie University, Halifax, NS, Canada.
²³ Division of Vascular and Endovascular Surgery, Department of Surgery and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
²⁴ University of Calgary, Calgary, AB, Canada.
²⁵ Alberta Health Services, Calgary, AB, Canada.
²⁶ Ernest E. Moore Shock Trauma Center, University of Colorado, Denver, CO, USA.
²⁷ Department of Surgery, Denver Health, Denver, CO, USA.
²⁸ John Hunter Hospital, Newcastle, NSW, Australia.
²⁹ General Surgery Department of Koutlimbaneio, Triantafylleio General Hospital of Larissa, Larissa, Thessaly, Greece.
³⁰ General and Emergency Surgery, School of Medicine and Surgery, Milano-Bicocca University, Monza, Italy.
³¹ Chirurgia Generale E d'Urgenza, Ospedale M. Bufalini - Cesena, AUSL Della Romagna, Cesena, Italy.
³² Department of Precision and Regenerative Medicine and Ionian Area, Unit of Academic General Surgery "V. Bonomo", University of Bari "A. Moro", Bari, Italy.
³³ Trauma and Acute Care Surgery, General Surgery, St. Michael's Hospital, Toronto, ON, Canada.
³⁴ General Surgery Department, Istanbul Medeniyet University School of Medicine Istanbul, Istanbul, Turkey.
³⁵ General Surgery Unit, Ospedale M. Buffalini Di Cesena, Cesena, Italy.
³⁶ College of Medicine and Health Sciences, United Arab Emirates University, Al-Ain, United Arab Emirates.
³⁷ Division of Surgical Oncology, Afe Babalola University Multisystem Hospital, Ado-Ekiti, Nigeria.
³⁸ University Hospital Centre Zagreb, School of Medicine University of Zagreb, Zagreb, Croatia.
³⁹ Virgen de la Arrixaca University Hospital IMIB-Arrixaca, Ctra. Madrid-Cartagena, S/N, Murcia, Spain.
⁴⁰ Bagcilar Research and Training Hospital, Istanbul, Turkey.
⁴¹ Nurse Master of Nursing, Professor and Coordinator of the teaching-service relationship, Faculty of Health Sciences, University of Sucre, Sincelejo, Colombia.
⁴² Trauma and Emergency Surgery Unit. General, Digestive and Transplantation Surgery Department, University Regional Hospital of Málaga, Malaga, Spain.
⁴³ Department of Surgery, Bizerte Hospital, Bizerte, Tunisia.
⁴⁴ Scripps Clinic Medical Group, La Jolla, CA, USA.
⁴⁵ Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
⁴⁶ Department of Surgery, University of Milan Medical School, Milan, Italy.
⁴⁷ Department of Surgery, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.
⁴⁸ Department of Surgery, General Hospital Madonna del Soccorso, San Benedetto del Tronto, Italy.
⁴⁹ General Surgery Unit, UO Chirurgia Generale - Ospedale Maggiore Di Cremona, Cremona, Italy.
⁵⁰ Department of Visceral and Digestive Surgery, Monastir University, Monastir, Tunisia.
⁵¹ Department of Surgery, Azienda Sanitaria Provinciale Di Cosenza, Cosenza, Italy.
⁵² Fondazione Policlinico Campus Bio-Medico, University Campus Bio-Medico of Rome, Rome, Italy.
⁵³ Colorectal and Digestive Surgery Unit-DIGEST Department, Beaujon University Hospital AP-HP, University Paris Cité, Clichy, France.
⁵⁴ Department of General Surgery, Cattinara University Hospital, Trieste, Italy.
⁵⁵ Department of Proctology, Clinic for Surgery, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina.
⁵⁶ Department of General Surgery, University of Insubria, University Hospital of Varese, ASST Sette Laghi, Regione Lombardia, Italy.
⁵⁷ Unit of Digestive and Metabolic Minimally Invasive Surgery, Clinique Saint Louis, Poissy, Poissy, Ile de France, France.
⁵⁸ Unit of Emergency and General Surgery, Guastalla Hospital, AUSL Reggio Emilia, Guastalla, Italy.
⁵⁹ Chirurgie Digestive, Service de Chirurgie Vasculaire Et, Générale University Hospital of Bordeaux FR, Bordeaux, France.
⁶⁰ Fondazione Policlinico A, Gemelli IRCCS, Rome, Italy.
⁶¹ Department Head of Surgery, Infermi Hospital, Rimini, Italy.
⁶² Emergency and General Consultant Surgeon, Nuovo Ospedale "S. Stefano", Azienda ASL Toscana Centro, Prato, Italy.
⁶³ Surgery Unit, Hospital Universitário Terezinha de Jesus, SUPREMA, Juiz de Fora, Brazil.
⁶⁴ Department of Surgery, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah, Kota Kinabalu, Sabah, Malaysia.
⁶⁵ Research Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.
⁶⁶ Hospital Umum Sarawak/Universiti Malaysia, Sarawak, Malaysia.
⁶⁷ Hospital Sultanah Aminah, Johor Bahru, Malaysia.
⁶⁸ Universiti Sains Islam Malaysia, Nilai, Malaysia.
⁶⁹ General Surgery, University Hospitals, Sussex, UK.
⁷⁰ Universidad de Sucre, Medicine Program, Clínica Santa María, Sincelejo, Colombia.
⁷¹ First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, Lublin, Poland.
⁷² International Fluid Academy, Lovenjoel, Belgium.
⁷³ Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.
⁷⁴ University of Calgary, Calgary, Canada.
⁷⁵ Tameside and Glossop Integrated Care NHSFT, Ashton-under-Lyne, UK.
⁷⁶ Department of General Surgery, Madonna del Soccorso Hospital - San Benedetto del Tronto, Italy, Italy.
⁷⁷ Department of Surgery, General University Hospital of Patras, Rio, Greece.
⁷⁸ Department of Surgical Science, Cagliari State University, Cagliari, Italy.
⁷⁹ Hospital Angkatan Tentera Tuanku Mizan, Kuala Lumpur, Malaysia.
⁸⁰ Department of General Surgery, King George's Medical University, Lucknow, UP, India.
⁸¹ School of Medical Sciences & Hospital, Universiti Sains Malaysia, Kelantan, Malaysia.
⁸² University Hospital Careggi, Florence, Italy.
⁸³ Department of Emergency Surgery, Cagliari University Hospital, Cagliari, Italy.
⁸⁴ Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Sacred Heart, Rome, Italy.
⁸⁵ Department of General Surgery, Hüseyin Kemal Raşa, Anadolu Medical Center, Kocaeli, Turkey.
⁸⁶ Division of General and Minimally Invasive Surgery, ASST Valle Olona, Busto Arsizio, Italy.
⁸⁷ Emergency Surgery Unit and Trauma Team, Careggi University Hospital, Florence, Italy.
⁸⁸ Plovdiv Medical University, Plovdiv, Bulgaria.
⁸⁹ Department of Surgery, South Ural State Medical University, Chelyabinsk City, Russia.
⁹⁰ Department of General Surgery, University of Bologna, Bologna, Italy.
⁹¹ Fiona Stanley Hospital, Perth, WA, Australia.
⁹² Clinica Santa Maria, Sincelejo, Colombia.
⁹³ Military Institute of Medicine, Warsaw, Poland.
⁹⁴ Department of General Surgery, University Hospital of Heraklion, Crete, Greece.
⁹⁵ St Vincent's University Hospital, Dublin, Ireland.
⁹⁶ Department of Surgery, School of Medical Sciences and Hospital USM, Universiti Sains Malaysia, Georgetown, Malaysia.

PMID: 37170123
PMCID: PMC10173926
DOI: 10.1186/s13017-023-00500-z

Randomized Controlled Trial

The unrestricted global effort to complete the COOL trial

Andrew W Kirkpatrick et al. World J Emerg Surg. 2023.

. 2023 May 11;18(1):33.

doi: 10.1186/s13017-023-00500-z.

Authors

Affiliations

¹ Departments of Surgery and Critical Care Medicine, University of Calgary, Foothills Medical Centre, Calgary, AB, EG23T2N 2T9, Canada. Andrew.kirkpatrick@albertahealthservices.ca.
² General, Emergency and Trauma Surgery Department, Pisa University Hospital, Pisa, Italy.
³ Abdominal Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
⁴ Departments of Critical Care Medicine and Surgery, Dalhousie University, Halifax, NS, Canada.
⁵ Department of Surgery, Bufalini Hospital, Cesena, Italy.
⁶ Department of Surgery, Londrina State University, and National COOL Coordinator for Brazil, Londrina, Brazil.
⁷ Departments of Critical Care Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
⁸ Department of Clinical Neuroscience and Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary and Foothills Medical Centre, Calgary, AB, Canada.
⁹ General Surgery I, San Matteo Hospital Pavia, University of Pavia, Pavia, Italy.
¹⁰ Emergency Surgery and Trauma Center, University of Pisa, Pisa, Italy.
¹¹ 4th Department of Surgery, Medical School, Aristotle University of Thessaloniki, General Hospital "George Papanikolaou", Thessaloniki, Greece.
¹² Letterkenny University Hospital, Donegal, Ireland.
¹³ University of Samsun, Samsun Training and Research Hospital, Samsun, Turkey.
¹⁴ Department of Surgery, University of British Columbia, Vancouver, BC, Canada.
¹⁵ Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Espoo, Finland.
¹⁶ Chief Anesthesiology, Bufalini Hospital, Cesena, Italy.
¹⁷ Global Project Manager, COOL Trial and the TeleMentored Ultrasound Supported Medical Interventions Research Group, Calgary, AB, Canada.
¹⁸ Departments of Surgery and Critical Care Medicine, University of British Columbia, Vancouver, BC, Canada.
¹⁹ Department of Surgery, Macerata Hospital, Global Alliance for Infections in Surgery, Macerata, Italy.
²⁰ Trauma and Acute Care Surgery, Foothills Medical Center, Calgary, AB, Canada.
²¹ Departments of Surgery and Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada.
²² Department of Surgery, NSHA-Queen Elizabeth II Health Sciences Center, Dalhousie University, Halifax, NS, Canada.
²³ Division of Vascular and Endovascular Surgery, Department of Surgery and School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada.
²⁴ University of Calgary, Calgary, AB, Canada.
²⁵ Alberta Health Services, Calgary, AB, Canada.
²⁶ Ernest E. Moore Shock Trauma Center, University of Colorado, Denver, CO, USA.
²⁷ Department of Surgery, Denver Health, Denver, CO, USA.
²⁸ John Hunter Hospital, Newcastle, NSW, Australia.
²⁹ General Surgery Department of Koutlimbaneio, Triantafylleio General Hospital of Larissa, Larissa, Thessaly, Greece.
³⁰ General and Emergency Surgery, School of Medicine and Surgery, Milano-Bicocca University, Monza, Italy.
³¹ Chirurgia Generale E d'Urgenza, Ospedale M. Bufalini - Cesena, AUSL Della Romagna, Cesena, Italy.
³² Department of Precision and Regenerative Medicine and Ionian Area, Unit of Academic General Surgery "V. Bonomo", University of Bari "A. Moro", Bari, Italy.
³³ Trauma and Acute Care Surgery, General Surgery, St. Michael's Hospital, Toronto, ON, Canada.
³⁴ General Surgery Department, Istanbul Medeniyet University School of Medicine Istanbul, Istanbul, Turkey.
³⁵ General Surgery Unit, Ospedale M. Buffalini Di Cesena, Cesena, Italy.
³⁶ College of Medicine and Health Sciences, United Arab Emirates University, Al-Ain, United Arab Emirates.
³⁷ Division of Surgical Oncology, Afe Babalola University Multisystem Hospital, Ado-Ekiti, Nigeria.
³⁸ University Hospital Centre Zagreb, School of Medicine University of Zagreb, Zagreb, Croatia.
³⁹ Virgen de la Arrixaca University Hospital IMIB-Arrixaca, Ctra. Madrid-Cartagena, S/N, Murcia, Spain.
⁴⁰ Bagcilar Research and Training Hospital, Istanbul, Turkey.
⁴¹ Nurse Master of Nursing, Professor and Coordinator of the teaching-service relationship, Faculty of Health Sciences, University of Sucre, Sincelejo, Colombia.
⁴² Trauma and Emergency Surgery Unit. General, Digestive and Transplantation Surgery Department, University Regional Hospital of Málaga, Malaga, Spain.
⁴³ Department of Surgery, Bizerte Hospital, Bizerte, Tunisia.
⁴⁴ Scripps Clinic Medical Group, La Jolla, CA, USA.
⁴⁵ Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
⁴⁶ Department of Surgery, University of Milan Medical School, Milan, Italy.
⁴⁷ Department of Surgery, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.
⁴⁸ Department of Surgery, General Hospital Madonna del Soccorso, San Benedetto del Tronto, Italy.
⁴⁹ General Surgery Unit, UO Chirurgia Generale - Ospedale Maggiore Di Cremona, Cremona, Italy.
⁵⁰ Department of Visceral and Digestive Surgery, Monastir University, Monastir, Tunisia.
⁵¹ Department of Surgery, Azienda Sanitaria Provinciale Di Cosenza, Cosenza, Italy.
⁵² Fondazione Policlinico Campus Bio-Medico, University Campus Bio-Medico of Rome, Rome, Italy.
⁵³ Colorectal and Digestive Surgery Unit-DIGEST Department, Beaujon University Hospital AP-HP, University Paris Cité, Clichy, France.
⁵⁴ Department of General Surgery, Cattinara University Hospital, Trieste, Italy.
⁵⁵ Department of Proctology, Clinic for Surgery, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina.
⁵⁶ Department of General Surgery, University of Insubria, University Hospital of Varese, ASST Sette Laghi, Regione Lombardia, Italy.
⁵⁷ Unit of Digestive and Metabolic Minimally Invasive Surgery, Clinique Saint Louis, Poissy, Poissy, Ile de France, France.
⁵⁸ Unit of Emergency and General Surgery, Guastalla Hospital, AUSL Reggio Emilia, Guastalla, Italy.
⁵⁹ Chirurgie Digestive, Service de Chirurgie Vasculaire Et, Générale University Hospital of Bordeaux FR, Bordeaux, France.
⁶⁰ Fondazione Policlinico A, Gemelli IRCCS, Rome, Italy.
⁶¹ Department Head of Surgery, Infermi Hospital, Rimini, Italy.
⁶² Emergency and General Consultant Surgeon, Nuovo Ospedale "S. Stefano", Azienda ASL Toscana Centro, Prato, Italy.
⁶³ Surgery Unit, Hospital Universitário Terezinha de Jesus, SUPREMA, Juiz de Fora, Brazil.
⁶⁴ Department of Surgery, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah, Kota Kinabalu, Sabah, Malaysia.
⁶⁵ Research Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China.
⁶⁶ Hospital Umum Sarawak/Universiti Malaysia, Sarawak, Malaysia.
⁶⁷ Hospital Sultanah Aminah, Johor Bahru, Malaysia.
⁶⁸ Universiti Sains Islam Malaysia, Nilai, Malaysia.
⁶⁹ General Surgery, University Hospitals, Sussex, UK.
⁷⁰ Universidad de Sucre, Medicine Program, Clínica Santa María, Sincelejo, Colombia.
⁷¹ First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, Lublin, Poland.
⁷² International Fluid Academy, Lovenjoel, Belgium.
⁷³ Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India.
⁷⁴ University of Calgary, Calgary, Canada.
⁷⁵ Tameside and Glossop Integrated Care NHSFT, Ashton-under-Lyne, UK.
⁷⁶ Department of General Surgery, Madonna del Soccorso Hospital - San Benedetto del Tronto, Italy, Italy.
⁷⁷ Department of Surgery, General University Hospital of Patras, Rio, Greece.
⁷⁸ Department of Surgical Science, Cagliari State University, Cagliari, Italy.
⁷⁹ Hospital Angkatan Tentera Tuanku Mizan, Kuala Lumpur, Malaysia.
⁸⁰ Department of General Surgery, King George's Medical University, Lucknow, UP, India.
⁸¹ School of Medical Sciences & Hospital, Universiti Sains Malaysia, Kelantan, Malaysia.
⁸² University Hospital Careggi, Florence, Italy.
⁸³ Department of Emergency Surgery, Cagliari University Hospital, Cagliari, Italy.
⁸⁴ Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Sacred Heart, Rome, Italy.
⁸⁵ Department of General Surgery, Hüseyin Kemal Raşa, Anadolu Medical Center, Kocaeli, Turkey.
⁸⁶ Division of General and Minimally Invasive Surgery, ASST Valle Olona, Busto Arsizio, Italy.
⁸⁷ Emergency Surgery Unit and Trauma Team, Careggi University Hospital, Florence, Italy.
⁸⁸ Plovdiv Medical University, Plovdiv, Bulgaria.
⁸⁹ Department of Surgery, South Ural State Medical University, Chelyabinsk City, Russia.
⁹⁰ Department of General Surgery, University of Bologna, Bologna, Italy.
⁹¹ Fiona Stanley Hospital, Perth, WA, Australia.
⁹² Clinica Santa Maria, Sincelejo, Colombia.
⁹³ Military Institute of Medicine, Warsaw, Poland.
⁹⁴ Department of General Surgery, University Hospital of Heraklion, Crete, Greece.
⁹⁵ St Vincent's University Hospital, Dublin, Ireland.
⁹⁶ Department of Surgery, School of Medical Sciences and Hospital USM, Universiti Sains Malaysia, Georgetown, Malaysia.

PMID: 37170123
PMCID: PMC10173926
DOI: 10.1186/s13017-023-00500-z

Abstract

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 ).

Keywords: Global health; Intraperitoneal sepsis; Laparotomy; Multiple organ dysfunction; Open abdomen; Peritonitis; Randomized controlled trial; Septic shock.

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Conflict of interest statement

Andrew W Kirkpatrick serves as the PI of the COOL trial, as a member of the Canadian Forces Medical Services, and has consulted for the 3 m/Acelity Corporation, Zoll Medical, Innovative Trauma Care, CSL Behring, and the Statesman’s Group. Federico Coccolini, Matti Tolonen reported no declarations. Samuel Minor reported receiving research support and speaking honoraria from COOK Biotech. Emanuel Gois Jr. reported no declarations. Fausto Catena, Christopher J Doig, Michael D Hill, Luca Ansaloni, Massimo Chiurgi, Dario Tartaglia, Orestis Ioannidis reported no declarations. Michael Sugrue reported consultancy for 3 M/Acelity and Novus Scientific. Elif Colak: reported no declarations. S Morad Hameed reported being the Founder of T6 Health Systems. Hanna Lampela, Vanni Agnoletti reported no declarations. Jessica L McKee reported consultancies with the Aceso, Innovative Trauma Care, Andrew W Kirkpatrick, and Zoll Corporations, as well as consulting with the Geneva Foundation and South Trail Psychology. Naisan Garraway, Massimo Sartelli, Chad G Ball reported no declarations. Neil G Parry reported being a medical advisor for Front Line Medical Technologies – Cobra REBOA. Kelly Voght, Lisa Julien, Jenna Kroeker reported no declarations. Derek J Roberts, Peter Faris, Corina Tiruta, Ernest E Moore, Lee Ann Ammons, Elissavet Anestiadou, Cino Bendinelli, Konstantinos Bouliaris, Rosemarry Carroll, Marco Ceresoli, Francesco Favi, Angela Gurrado, Joao Rezende-Neto, Arda Isik, Camilla Cremonini, Silivia Strambi, Georgios Konstantoudakis, Mario Testini, Sandy Trpcic, Alessandro Pasculli, Erika Picariello, Fikri Abu-Zidan, Ademola Adeyeye, Goran Augustin, Felipe Alconchel, Yuksel Altinel, Luz Adriana Hernandez Amin, José Manuel-Narváez, Oussama Baraket, Walter L Biffl, Gian Luca Baiocchi, Luigi Bonavina, Giuseppe Brisinda, Luca Cardinali, Andrea Celotti, Mohamed Chaouch, Maria Michela Chiarello, Gianluca Costa, Nicola de’Angelis, Nicolo de Manzini, Samir Delibegovic, Salomone Di Saverio, Belinda De Simone reported no declarations. Dr Vincent Dubuisson received speaking honoraria from 3 M-Acelity in 2021 for a conference about how to manage an OA, at the congress of the French Association of Surgery. Pietro Fransvea, Luca Garulli, Alessio Giordano, Carlos Gomes, Firdaus Hayati, Jinjian Huang, Aini Fahriza Ibrahim, Tan Jih Huei, Ruhi Fadzlyana Jailani, Mansoor Khan, Alfonso Palmieri Luna reported no declarations. Manu L.N.G. Malbrain reported he is co-founder, past-President and current Treasurer of WSACS (The Abdominal Compartment Society, http://www.wsacs.org). He is a member of the medical advisory Board of Pulsion Medical Systems (part of Getinge group), Serenno Medical, Potrero Medical, Sentinel Medical and Baxter. He consults for BBraun, Becton Dickinson, ConvaTec, Spiegelberg, and Holtech Medical and received speaker's fees from PeerVoice. He holds stock options for Serenno and Potrero. Sanjay Marwah, Paul McBeth, Andrei Mihailescu, Alessia Morello, Francesk Mulita, Valentia Murzi, Ahmad Tarmizi Mohammad, Simran Parmar, Ajay Pal, Michael Pak-Kai Wong, Desire Pantalone, Mauro Podda, Caterina Puccioni, Kemal Rasa, Jianan Ren, Francesco Roscio, Antonio Gonzalez-Sanchez, Gabriele Sganga, Maximilian Scheiterle, Mihail Slavchev, Dmitry Smirnov, Lorenzo Tosi, Anand Trivedi, Jaime Andres Gonzalez Vega, Maciej Waledziak, Sofia Xenaki, Desmond Winter, Xiuwen Wu, Andee Dzulkarnean Zakaria reported no declarations.

Figures

**Fig. 3**
COOL study case report form. The Case Report Form is a extensive document that can be accessed online at Study Documents – COOL Study, but Investigators are encouraged to complete the form on-line where it will be securely entered into the University of Calgary REDCap (R esearch E lectronic D ata Cap ture) database.

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References

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The unrestricted global effort to complete the COOL trial

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The unrestricted global effort to complete the COOL trial

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