Dataset Information

The HAC Trial (Harmonic for Acute Cholecystitis) Study. Randomized, double-blind, controlled trial of Harmonic(H) versus Monopolar Diathermy (M) for laparoscopic cholecystectomy (LC) for acute cholecystitis (AC) in adults.

ABSTRACT: 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.The HARMONIC SCALPEL (H) is the leading ultrasonic cutting and coagulating surgical device, offering surgeons important benefits including: minimal lateral thermal tissue damage, minimal charring and desiccation.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.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%).However there are not prospective randomized controlled trials showing the advantages of H compared to MD (the commonly used electrical scalpel) in LC.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.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.ClinicalTrials.gov Identifier: NCT00746850.

SUBMITTER: Catena F

PROVIDER: S-EPMC2693511 | biostudies-literature | 2009 May

REPOSITORIES: biostudies-literature

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The HAC Trial (Harmonic for Acute Cholecystitis) Study. Randomized, double-blind, controlled trial of Harmonic(H) versus Monopolar Diathermy (M) for laparoscopic cholecystectomy (LC) for acute cholecystitis (AC) in adults.

Catena Fausto F Ansaloni Luca L Di Saverio Salomone S Gazzotti Filippo F Coccolini Federico F Pinna Antonio Daniele AD

Trials 20090526

<h4>Background</h4>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 duc ...[more]

PMID: 19470152

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Project description:BackgroundAcute cholecystitis is one of the most common emergent surgeries. As a safe alternative in challenging operations, laparoscopic subtotal cholecystectomy (LSC) is widely used. We questioned whether the results in acute cholecystitis cases changed with a history of endoscopic retrograde cholangiopancreatography (ERCP). When we searched the literature, we could not find a study focusing on the subtotal cholestectomy results in acute cholecystitis. In our study, we aimed to investigate whether the history of ERCP affects the rates of subtotal cholecystectomy (SC) in acute cholecystitis.MethodsThe results of patients (n=470) who underwent surgery for acute cholecystitis at our clinic between 2016 and 2019 were retrospectively evaluated. The patients were divided into two groups according to their history of ERCP. The primary outcome was the SC rate. The secondary outcomes were conversion to open, postoperative complications, serious complications, operative duration, and length of hospital stay.ResultsThe standard group included 437 patients, whereas the ERCP group included 33 patients. A total of 16 patients underwent SC, with 15 in the standard group and 1 in the ERCP group. There was no significant difference in terms of SC rates between groups (P=0.902). While four cases of operation were completed with conversion to open in the non-ERCP group, no conversion was seen in the ERCP group (P=0.581). No significant differences were detected between the groups in terms of complications, serious compli-cations, operation duration, length of hospital stay, and mortality.ConclusionThe results of this study showed that ERCP is not related to an increased rate of SC and conversion in patients with acute cholecystitis. Laparoscopic cholecystectomy for acute cholecystitis can be safely performed in patients with a history of ERCP. LSC is a safe procedure in challenging patients, and fenestrating SC can be preferred to avoid hazardous consequences in such cases.

Project description:BackgroundSevere adhesions and fibrosis between the posterior wall of the gallbladder and liver bed often render total cholecystectomy after percutaneous transhepatic gallbladder drainage (PTGBD) difficult, leading to high open conversion rates. Since the publication of Tokyo Guidelines 2018 (TG18), our policy has shifted from open conversion to subtotal cholecystectomy (SC) when total laparoscopic cholecystectomy for difficult cases of cholecystitis is not feasible. Recently, SC has been frequently applied as bailout surgery for complicated cholecystitis. Nonetheless, the efficacy and validity of laparoscopic SC after PTGBD remain unclear. This study aimed to evaluate the safety and feasibility of laparoscopic SC after PTGBD for grade II or III acute cholecystitis (AC) by comparing two periods of altered surgical strategies.MethodsThis retrospective cohort study was conducted between January 2013 and December 2020. A total of 44 eligible patients with grade II or III AC were divided according to the time of cholecystitis onset into the pre-TG18 group (2013-2017, n = 17) and post-TG18 group (2018-2020, n = 27). Patients' background demographics, surgical method, surgical results, and postoperative complications were compared.ResultsThe interval between PTGBD and surgery was significantly longer in the post-TG18 group than in the pre-TG18 group (15 [interquartile range: 9-42] days vs. 8 [4-11] days; P = 0.010). The frequency of laparoscopic cholecystectomy significantly increased from 52.9% in the pre-TG18 group to 88.9% in the post-TG18 group (P = 0.007), whereas the frequency of SC was 23.5% and 40.7%, respectively, which showed no statistically significant difference (P = 0.241). However, the rate of laparoscopic SC significantly increased from 0 to 90.9% among 15 SC cases, whereas the rate of open SC significantly plummeted from 100 to 9.1% (P = 0.001). Significant differences in the operative time, amount of intraoperative bleeding, and incidence of postoperative complications (wound infection and subhepatic abscess) were not observed. Mortality, bile leakage, and bile duct injury did not occur in either group.ConclusionsFor grade II or III AC after PTGBD, aggressive adoption of SC increased the completion rate of laparoscopic surgery. Laparoscopic SC is a safe and feasible treatment option.

Dataset Information

The HAC Trial (Harmonic for Acute Cholecystitis) Study. Randomized, double-blind, controlled trial of Harmonic(H) versus Monopolar Diathermy (M) for laparoscopic cholecystectomy (LC) for acute cholecystitis (AC) in adults.

Publications

The HAC Trial (Harmonic for Acute Cholecystitis) Study. Randomized, double-blind, controlled trial of Harmonic(H) versus Monopolar Diathermy (M) for laparoscopic cholecystectomy (LC) for acute cholecystitis (AC) in adults.

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