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首页> 外文期刊>World Journal of Emergency Surgery >The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis
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The HAC trial (harmonic for acute cholecystitis): a randomized, double-blind, controlled trial comparing the use of harmonic scalpel to monopolar diathermy for laparoscopic cholecystectomy in cases of acute cholecystitis

机译：HAC试验（谐波治疗急性胆囊炎）：一项随机，双盲，对照试验，比较了在急性胆囊炎病例中，将腹腔镜手术刀与单极透热疗法在腹腔镜胆囊切除术中的应用

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Background The HARMONIC SCALPEL (H) is an advanced ultrasonic cutting and coagulating surgical device with important clinical advantages, such as: reduced ligature demand; greater precision due to minimal lateral thermal tissue damage; minimal smoke production; absence of electric corrents running through the patient. However, there are no prospective RCTs demonstrating the advantages of H compared to the conventional monopolar diathermy (MD) during laparoscopic cholecystectomy (LC) in cases of acute cholecystitis (AC). Methods This study was a prospective, single-center, randomized trial (Trial Registration Number: NCT00746850) designed to investigate whether the use of H can reduce the incidence of intra-operative conversion during LC in cases of AC, compared to the use of MD. Patients were divided into two groups: both groups underwent early LC, within 72 hours of diagnosis, using H and MD respectively (H = experimental/study group, MD = control group). The study was designed and conducted in accordance with the regulations of Good Clinical Practice. Results 42 patients were randomly assigned the use of H (21 patients) or MD (21 patients) during LC. The two groups were comparable in terms of basic patient characteristics. Mean operating time in the H group was 101.3 minutes compared to 106.4 minutes in the control group (p=ns); overall blood loss was significantly lower in the H group. Conversion rate was 4.7% for the H group, which was significantly lower than the 33% conversion rate for the control group (p Conclusions The use of H appears to correlate with reduced rates of laparoscopic-open conversion. Given this evidence, H may be more suitable than MD for technically demanding cases of AC.
机译：背景技术HARMONIC SCALPEL（H）是一种先进的超声切割和凝固手术设备，具有重要的临床优势，例如：减少结扎需求;由于最小的侧面热组织损伤而提高了精度;产生的烟雾最少;病人身上没有电。但是，在急性胆囊炎（AC）的腹腔镜胆囊切除术（LC）期间，尚无前瞻性RCT证明H与常规单极透热疗法（MD）相比具有优势。方法：该研究是一项前瞻性，单中心，随机试验（注册号：NCT00746850），旨在研究与使用MD相比，使用H是否可以降低LC患者AC期间术中转换的发生率。 。将患者分为两组：两组均在诊断后72小时内分别接受了H和MD的早期LC检查（H =实验/研究组，MD =对照组）。该研究是根据《良好临床规范》的规定设计和进行的。结果42例患者在LC期间被随机分配使用H（21例）或MD（21例）。两组患者的基本特征具有可比性。 H组的平均手术时间为101.3分钟，而对照组为106.4分钟（p = ns）。 H组的总体失血量明显降低。 H组的转化率为4.7％，大大低于对照组的33％的转化率（p结论H的使用似乎与腹腔镜开腹转化率降低相关。鉴于这一证据，H可能是比MD更适合AC的技术要求较高的情况。

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