The unrestricted global effort to complete the COOL trial

World Journal of Emergency Surgery

Research

Elissavet Anestiadou¹  Orestis Ioannidis¹  Matti Tolonen²  Corina Tiruta³  Yuksel Altinel⁴  Vanni Agnoletti⁵  Francesco Favi⁶  Vincent Dubuisson⁷  Jaime Andres Gonzalez Vega⁸  Fikri Abu-Zidan⁹  Nicola de’Angelis^1,10  Gianluca Garulli^1,11  Michael D. Hill^1,12  Gian Luca Baiocchi^1,13  Mauro Podda^1,14  Hanna Lampela^1,15  Nicolo De Manzini^1,16  Kemal Rasa^1,17  Ajay Pak^1,18  Alessia Morello^1,19  Sofia Xenaki^2,20  Lorenzo Tosi^2,21  Salomone Di Saverio^2,22  Angela Gurrado^2,23  Alessandro Pasculli^2,23  Mario Testini^2,23  Samir Delibegovic^2,24  Maria Chiarello^2,25  Oussama Baraket^2,26  Fausto Catena^2,27  Lee Anne Ammons^2,28  Firdaus Hayati^2,29  Giuseppe Brisinda^3,30  Luca Cardinali^3,31  Francesk Mulita^3,32  Emanuel Gois^3,33  Massimo Sartelli^3,34  Lisa Julien^3,35  Andee Dzulkarnean Zakaria^3,36  Zaidi Zakaria^3,36  Dmitry Smirnov^3,37  S. Morad Hameed^3,38  Luigi Bonavina^3,39  Valentina Murzi^4,40  Mohamed Chaouch^4,41  Christopher J. Doig^4,42  Samuel Minor^4,43  Naisan Garraway^4,44  Jenna Kroeker^4,44  Andrew W. Kirkpatrick^4,45  Neil G. Parry^4,46  Kelly Voght^4,46  Francesco Roscio^4,47  Ademola Adeyeye^4,48  Derek J. Roberts^4,49  Maximilian Scheiterle^5,50  Silivia Strambi^5,51  Dario Tartaglia^5,51  Massimo Chiarugi^5,51  Camilla Cremonini^5,51  Alessio Giordano^5,52  Ernest E. Moore^5,53  Anand Trivedi^5,54  Manu L. N. G. Malbrain^5,55  Pietro Fransvea^5,56  Gianluca Costa^5,57  Caterina Puccioni^5,58  Gabriele Sganga^5,58  Georgios Koukoulis^5,59  Konstantinos Bouliaris^5,59  Arda Isik^6,60  Luca Ansaloni^6,61  Erika Picariello^6,62  Andrea Celotti^6,63  Mansoor Khan^6,64  Marco Ceresoli^6,65  Federico Coccolini^6,66  Jessica L. McKee^6,67  Ahmad Tarmizi Mohammad^6,68  Tan Jih Huei^6,69  Aini Fahriza Ibrahim^7,70  Cino Bendinelli^7,71  Rosemarry Carroll^7,71  Michael Sugrue^7,72  Maciej Waledziak^7,73  Luz Adriana Hernandez Amin^7,74  Mihail Slavchev^7,75  Sanjay Marwah^7,76  Xiuwen Wu^7,77  Jianan Ren^7,77  Jinjian Huang^7,77  Michael Pak-Kai Wong^7,78  Walter L. Biffl^7,79  Desmond Winter^8,80  Carlos Gomes^8,81  Andrei Mihailescu^8,82  Chad G. Ball^8,83  Sandy Trpcic^8,84  Joao Rezende-Neto^8,84  José Manuel Aranda-Narváez^8,85  Antonio Gonzalez-Sanchez^8,85  Belinda De Simone^8,86  Alfonso Palmieri Luna^8,87  Ruhi Fadzlyana Jailani^8,88  Desire Pantalone^8,89  Goran Augustin^9,90  Simran Parmar^9,91  Peter Faris^9,91  Paul McBeth^9,92  Elif Colak^9,93  Felipe Alconchel^9,94 

[1] 4th Department of Surgery, Medical School, Aristotle University of Thessaloniki, General Hospital “George Papanikolaou”, Thessaloniki, Greece;Abdominal Center, Helsinki University Hospital and University of Helsinki, Helsinki, Finland;Alberta Health Services, Calgary, AB, Canada;Bagcilar Research and Training Hospital, Istanbul, Turkey;Chief Anesthesiology, Bufalini Hospital, Cesena, Italy;Chirurgia Generale E d’Urgenza, Ospedale M. Bufalini - Cesena, AUSL Della Romagna, Cesena, Italy;Chirurgie Digestive, Service de Chirurgie Vasculaire Et, Générale University Hospital of Bordeaux FR, Bordeaux, France;Clinica Santa Maria, Sincelejo, Colombia;College of Medicine and Health Sciences, United Arab Emirates University, Al-Ain, United Arab Emirates;Colorectal and Digestive Surgery Unit–DIGEST Department, Beaujon University Hospital AP-HP, University Paris Cité, Clichy, France;Department Head of Surgery, Infermi Hospital, Rimini, Italy;Department of Clinical Neuroscience and Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary and Foothills Medical Centre, Calgary, AB, Canada;Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy;Department of Emergency Surgery, Cagliari University Hospital, Cagliari, Italy;Department of Gastroenterological Surgery, Helsinki University Hospital and University of Helsinki, Espoo, Finland;Department of General Surgery, Cattinara University Hospital, Trieste, Italy;Department of General Surgery, Hüseyin Kemal Raşa, Anadolu Medical Center, Kocaeli, Turkey;Department of General Surgery, King George’s Medical University, Lucknow, UP, India;Department of General Surgery, Madonna del Soccorso Hospital - San Benedetto del Tronto, Italy, Italy;Department of General Surgery, University Hospital of Heraklion, Crete, Greece;Department of General Surgery, University of Bologna, Bologna, Italy;Department of General Surgery, University of Insubria, University Hospital of Varese, ASST Sette Laghi, Regione Lombardia, Italy;Department of Precision and Regenerative Medicine and Ionian Area, Unit of Academic General Surgery “V. Bonomo”, University of Bari “A. Moro”, Bari, Italy;Department of Proctology, Clinic for Surgery, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina;Department of Surgery, Azienda Sanitaria Provinciale Di Cosenza, Cosenza, Italy;Department of Surgery, Bizerte Hospital, Bizerte, Tunisia;Department of Surgery, Bufalini Hospital, Cesena, Italy;Department of Surgery, Denver Health, Denver, CO, USA;Department of Surgery, Faculty of Medicine and Health Sciences, Universiti Malaysia Sabah, Kota Kinabalu, Sabah, Malaysia;Department of Surgery, Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy;Department of Surgery, General Hospital Madonna del Soccorso, San Benedetto del Tronto, Italy;Department of Surgery, General University Hospital of Patras, Rio, Greece;Department of Surgery, Londrina State University, and National COOL Coordinator for Brazil, Londrina, Brazil;Department of Surgery, Macerata Hospital, Global Alliance for Infections in Surgery, Macerata, Italy;Department of Surgery, NSHA-Queen Elizabeth II Health Sciences Center, Dalhousie University, Halifax, NS, Canada;Department of Surgery, School of Medical Sciences and Hospital USM, Universiti Sains Malaysia, Georgetown, Malaysia;Department of Surgery, South Ural State Medical University, Chelyabinsk City, Russia;Department of Surgery, University of British Columbia, Vancouver, BC, Canada;Department of Surgery, University of Milan Medical School, Milan, Italy;Department of Surgical Science, Cagliari State University, Cagliari, Italy;Department of Visceral and Digestive Surgery, Monastir University, Monastir, Tunisia;Departments of Critical Care Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada;Departments of Critical Care Medicine and Surgery, Dalhousie University, Halifax, NS, Canada;Departments of Surgery and Critical Care Medicine, University of British Columbia, Vancouver, BC, Canada;Departments of Surgery and Critical Care Medicine, University of Calgary, Foothills Medical Centre, EG23T2N 2T9, Calgary, AB, Canada;Departments of Surgery and Medicine, Schulich School of Medicine and Dentistry, Western University, London, ON, Canada;Division of General and Minimally Invasive Surgery, ASST Valle Olona, Busto Arsizio, Italy;Division of Surgical Oncology, Afe Babalola University Multisystem Hospital, Ado-Ekiti, Nigeria;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;Emergency Surgery Unit and Trauma Team, Careggi University Hospital, Florence, Italy;Emergency Surgery and Trauma Center, University of Pisa, Pisa, Italy;Emergency and General Consultant Surgeon, Nuovo Ospedale “S. Stefano”, Azienda ASL Toscana Centro, Prato, Italy;Ernest E. Moore Shock Trauma Center, University of Colorado, Denver, CO, USA;Fiona Stanley Hospital, Perth, WA, Australia;First Department of Anaesthesiology and Intensive Therapy, Medical University of Lublin, Lublin, Poland;International Fluid Academy, Lovenjoel, Belgium;Fondazione Policlinico A, Gemelli IRCCS, Rome, Italy;Fondazione Policlinico Campus Bio-Medico, University Campus Bio-Medico of Rome, Rome, Italy;Fondazione Policlinico Universitario A. Gemelli IRCCS, Catholic University of Sacred Heart, Rome, Italy;General Surgery Department of Koutlimbaneio, Triantafylleio General Hospital of Larissa, Larissa, Thessaly, Greece;General Surgery Department, Istanbul Medeniyet University School of Medicine Istanbul, Istanbul, Turkey;General Surgery I, San Matteo Hospital Pavia, University of Pavia, Pavia, Italy;General Surgery Unit, Ospedale M. Buffalini Di Cesena, Cesena, Italy;General Surgery Unit, UO Chirurgia Generale - Ospedale Maggiore Di Cremona, Cremona, Italy;General Surgery, University Hospitals, Sussex, UK;General and Emergency Surgery, School of Medicine and Surgery, Milano-Bicocca University, Monza, Italy;General, Emergency and Trauma Surgery Department, Pisa University Hospital, Pisa, Italy;Global Project Manager, COOL Trial and the TeleMentored Ultrasound Supported Medical Interventions Research Group, Calgary, AB, Canada;Hospital Angkatan Tentera Tuanku Mizan, Kuala Lumpur, Malaysia;Hospital Sultanah Aminah, Johor Bahru, Malaysia;Hospital Umum Sarawak/Universiti Malaysia, Sarawak, Malaysia;John Hunter Hospital, Newcastle, NSW, Australia;Letterkenny University Hospital, Donegal, Ireland;Military Institute of Medicine, Warsaw, Poland;Nurse Master of Nursing, Professor and Coordinator of the teaching-service relationship, Faculty of Health Sciences, University of Sucre, Sincelejo, Colombia;Plovdiv Medical University, Plovdiv, Bulgaria;Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India;Research Institute of General Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China;School of Medical Sciences & Hospital, Universiti Sains Malaysia, Kelantan, Malaysia;Scripps Clinic Medical Group, La Jolla, CA, USA;St Vincent’s University Hospital, Dublin, Ireland;Surgery Unit, Hospital Universitário Terezinha de Jesus, SUPREMA, Juiz de Fora, Brazil;Tameside and Glossop Integrated Care NHSFT, Ashton-under-Lyne, UK;Trauma and Acute Care Surgery, Foothills Medical Center, Calgary, AB, Canada;Trauma and Acute Care Surgery, General Surgery, St. Michael’s Hospital, Toronto, ON, Canada;Trauma and Emergency Surgery Unit. General, Digestive and Transplantation Surgery Department, University Regional Hospital of Málaga, Malaga, Spain;Unit of Digestive and Metabolic Minimally Invasive Surgery, Clinique Saint Louis, Poissy, Poissy, Ile de France, France;Unit of Emergency and General Surgery, Guastalla Hospital, AUSL Reggio Emilia, Guastalla, Italy;Universidad de Sucre, Medicine Program, Clínica Santa María, Sincelejo, Colombia;Universiti Sains Islam Malaysia, Nilai, Malaysia;University Hospital Careggi, Florence, Italy;University Hospital Centre Zagreb, School of Medicine University of Zagreb, Zagreb, Croatia;University of Calgary, Calgary, AB, Canada;University of Calgary, Calgary, Canada;University of Samsun, Samsun Training and Research Hospital, Samsun, Turkey;Virgen de la Arrixaca University Hospital IMIB-Arrixaca, Ctra. Madrid-Cartagena, S/N, Murcia, Spain;

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

DOI  :  10.1186/s13017-023-00500-z

 received in 2023-02-21, accepted in 2023-04-13,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundSevere 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.MethodsThe 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.DiscussionOA 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).

【 授权许可】

CC BY   
© The Author(s) 2023

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