National survey on the treatment of acute appendicitis in Spain during the initial period of the COVID-19 pandemic

Introduction: The COVID-19 pandemic has had a significant impact on Spanish hospitals, which have had to allocate all available resources to treat these patients, reducing the ability to attend other common pathologies. The aim of this study is to analyze how the treatment of acute appendicitis has been affected.Methods: A national descriptive study was carried out by a online voluntary distribution of a specific questionnaire with Google Drive (TM) distributed by email by the Spanish Association of Surgeons (AEC) to all affiliated surgeons actually working in Spain (5203) opened from April 14th to April 24th.Results: We received 337 responses from 170 centers. During the first month of the pandemic the incidence of acute appendicitis has decreased. Although conservative management has increased, surgical option has been the most used in both simple and complicated appendicitis. Despite the fact that the laparoscopic approach continues to be the most widely used in our services, the open approach has increased during this pandemic period.Conclusion: Highlight the contribution of this study in terms of knowledge of the status of the treatment of acute appendicitis during this first month of the pandemic, being able to serve for a better possible organization in future waves of the pandemic and a reorganization of current protocols and management of acute appendicitis in a pandemic situation. (C) 2020 AEC. Published by Elsevier Espana, S.L.U. All rights reserved

The unrestricted global effort to complete the COOL trial

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 Intraperitoneal sepsis, Septic shock, Peritonitis, Open abdomen, Multiple organ dysfunction, Laparotomy, Randomized controlled trial, Global healthPeer reviewe