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).
Bismuth type 3 was the commonest ( 14) type of injury/ stricture followed by type 2 (3) and type 1 (2). There was 1 mortality following surgery due to bile leak followed by severe sepsis. Remaining 18 patients had excellent postoperative outcome without significant morbid.
presenting here the fate of the spilled over gall bladder stones during laparoscopic cholecystectomy in an old lady. Method: A 52 -year-old woman who presented with discharging sinus that developed four years after LC from one of post surgical site. Radiological studies showed a sinus tract of size around 8 cms. With an abscess formation at the sub hepatic region with some echoreflective structure inside. The whole of the sinus tract was excised and the collection drained. Multiple gall stones were found in the cavity which was spilled during her surgery. Results: The incidence of perforation ranged from 9% to 40% whereas stones retained in 1% e 13%.Recognised symptoms include abdominal pain, fever, abdominal abscess, and the presence of a sinus formation and present in variable time periods .It is crucial to minimise the number of stones spilled by meticulous dissection and use endo bag for specimen retrieval, attempt to retrieve all stray stones and to copiously irrigate the peritoneal cavity. Possibly the most important aspect in the management of stone spillage is documentation. Conclusion: Gallbladder perforation during is a reasonably common problem and may result in spilled stones and may lead to complications. Should spillage occur, clear documentation and a high index of suspicion should be maintained for early recognition and treatment of complications.
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