Summary: | <p>Abstract</p> <p>Background</p> <p>In the developmental stage of laparoscopic cholecystectomy (LC) it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis (AC). With increasing experience in laparoscopic surgery, a number of centers have reported on the use of laparoscopic cholecystectomy for acute cholecystitis, suggesting that it is technically feasible but at the expense of a high conversion rate, which can be up to 35 per cent and common bile duct lesions.</p> <p>The HARMONIC SCALPEL(R) (H) is the leading ultrasonic cutting and coagulating surgical device, offering surgeons important benefits including: minimal lateral thermal tissue damage, minimal charring and desiccation.</p> <p>Harmonic Scalpel technology reduces the need for ligatures with simultaneous cutting and coagulation: moreover there is not electricity to or through the patient Harmonic Scalpel has a greater precision near vital structures and it produces minimal smoke with improved visibility in the surgical field.</p> <p>In retrospective series LC performed with H was demonstrated feasible and effective with minimal operating time and blood loss: it was reported also a low conversion rate (3.9%).</p> <p>However there are not prospective randomized controlled trials showing the advantages of H compared to MD (the commonly used electrical scalpel) in LC.</p> <p>Methods/Design</p> <p>Aim of this RCT is to demonstrate that H can decrease the conversion rate compared to MD in LC for AC, without a significant increase of morbidity.</p> <p>The patients will be allocated in two groups: in the first group the patient will be submitted to early LC within 72 hours after the diagnosis with H while in the second group will be submitted to early LC within 72 hours with MD.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov Identifier: NCT00746850</p>
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