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).
Intraneural ganglion cysts are benign soft-tissue masses located in the epineurium of peripheral nerves. They originate from nearby joint connections via articular branches. Traumatic events seem to play a role in their pathogenesis as well. Clinical manifestations include pain over the area of the cyst, palpable tender mass, hypoesthesia, and muscle weakness depending on the affected nerve. Our case highlights an uncommon clinical manifestation of this entity with acute foot drop, as the primary symptom, without any previous traumatic event, enriching by this way the current diagnostic thinking process of clinical physicians. We report a case of a 42-year-old military officer who presented to our emergency department with acute foot drop that appeared during a march. Initially, the common peroneal palsy was misdiagnosed as L5-S1 disc herniation, but investigation with lumbar MRI scan led to rejection of our primary diagnosis. After performing EMG of the lower extremity and knee MRI, an intraneural ganglion cyst of the common peroneal nerve was diagnosed. Patient was treated with surgical decompression of the cyst, followed by ligation and complete resection of the articular branch, as well as disarticulation of the superior tibiofibular joint. At a twelve-month follow-up, the patient showed significant functional recovery. This is, to the best of our knowledge, the first case of intraneural ganglion cyst manifested with an acute complete foot drop without a clear prior traumatic event. We underline the need for a high index of suspicion when dealing with cases of acute peroneal palsy without any accompanying symptoms.
Background: The introduction of magnetically controlled capsule endoscopy overcame the restriction of passive capsule endoscopy movement, thus allowing an improved visualization of the gastrointestinal lumen, where other imaging studies seem to be unhelpful. The aim of this study is to systematically review the performance of magnetically controlled capsule endoscopy and evaluate its potential as a less invasive diagnostic method in the detection of gastric lesions. Methods: A systematic search was performed in PubMed (Medline), EMBASE, Google Scholar, Scopus, Who Global Health Library (GHL), Virtual Health Library (VHL), Clinicaltrials.gov, Cochrane Library, and ISI Web of Science databases. Proportion meta-analyses were performed to estimate the pooled sensitivity of magnetically controlled capsuled endoscopy in the detection of gastrointestinal lesions. Results: Among the 3026 studies that were initially assessed, 7 studies were finally included, with a total of 916 patients and 745 gastric lesions. The mean capsule endoscopy examination time was 21.92±8.87 minutes. The pooled overall sensitivity of magnetically controlled capsule endoscopy was 87% [95% confidence interval (CI), 84%-89%]. Subgroup analysis showed that the sensitivity of identifying gastric ulcers was 82% (95% CI: 71%-89%), gastric polyps was 82% (95% CI: 76%-87%), and gastric erosions was 95% (95% CI: 86%-98%). In general, magnetically controlled capsule endoscopy was well tolerated by the participants with minimal adverse events. Conclusion: The magnetically controlled capsule endoscopy demonstrated an acceptable sensitivity of identifying gastric lesions. Further prospective comparative studies are needed to identify the risks and benefits of this new technique, as well as to determine its role as a replacement for conventional gastroscopy.
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