Acute cholecystitis in high risk surgical patients: percutaneous cholecystostomy versus laparoscopic cholecystectomy (CHOCOLATE trial): Study protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Laparoscopic cholecystectomy in acute calculous cholecystitis in high risk patients can lead to significant morbidity and mortality. Percutaneous cholecystostomy may be an alternative treatment option but the current literature does not provide the surgical community with evidence based advice.</p> <p>Methods/Design</p> <p>The CHOCOLATE trial is a randomised controlled, parallel-group, superiority multicenter trial. High risk patients, defined as APACHE-II score 7-14, with acute calculous cholecystitis will be randomised to laparoscopic cholecystectomy or percutaneous cholecystostomy. During a two year period 284 patients will be enrolled from 30 high volume teaching hospitals. The primary endpoint is a composite endpoint of major complications within three months following randomization and need for re-intervention and mortality during the follow-up period of one year. Secondary endpoints include all other complications, duration of hospital admission, difficulty of procedures and total costs.</p> <p>Discussion</p> <p>The CHOCOLATE trial is designed to provide the surgical community with an evidence based guideline in the treatment of acute calculous cholecystitis in high risk patients.</p> <p>Trial Registration</p> <p>Netherlands Trial Register (NTR): <a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2666">NTR2666</a></p

2013 WSES guidelines for management of intra-abdominal infections

Peer reviewe

Living Up to Expectations

Abstract: To produce better quality software at reasonable cost, we propose requirements-based testing, in which testing is driven directly from the requirements and faults that prevent the product from meeting its requirements are detected. Our approach makes use of requirements in the form of goals and scenarios. From these we generate test scenarios that drive the system under test through particular paths of the scenarios, and a test harness that verifies the system follows the particular path and meets its conditions. Because our test scenarios are derived directly from the requirements, a major benefit of the process of writing test scenarios is the identification of poorly formulated requirements. We applied our approach to a sample software system and to mutants of it generated by MuJava. Our approach was effective at finding implementation faults that caused the system to diverge from the requirements. 1 Meeting the Requirements an

An automated approach for goal-driven, specification-based testing

This paper presents a specification-based approach and implementation architecture that addresses several known challenges including false positives and domain knowledge errors. Our approach begins with a system goal graph and functional goal plans. Source code is annotated with goals from plans the program is attempting to achieve; code is then precompiled to emit annotations at run time. Plans are automatically translated into a rule-based recognizer. An oracle is produced from the preand post-conditions associated with the plan’s goals. When the program is executed, goals and events are emitted and automatically tested against plans and expected results. This allows more efficient testing, including better recognition of false positives- correct results not matching plans-and domain knowledge errors- incorrect results from following intended plans. The concept is demonstrated for a small example and a larger publicly available case study in which we found a mismatch between stated requirements and actual program behavior. 1

An Automated Approach for Specification-based Testing Using Business Goals and Plans

This paper presents a specification-based testing approach and implementation architecture that addresses several known challenges including false positives and domain knowledge errors. Our approach begins with a system goal graph consisting of high level business goals which are refined to operational goals, and plans that describe how to strategically achieve these goals. Along the goal refinement process business rules can be derived and/or used for constructing plans. Source code is annotated with goals and events and precompiled to emit those at run time. Plans are automatically translated into a rule-based recognizer. An oracle is produced from the pre- and post-conditions associated with the plan’s goals. When the program is executed, goals and events are emitted and automatically tested against plans and oracles. The concept is demonstrated for a small example and a larger publicly available case study in which we found a mismatch between stated requirements and actual program behavior. 1