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

Abstract

BackgroundThe 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).MethodsThis 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.Results42 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<0.05). Post-operative morbidity rates differed slightly: 19% and 23% in the H and control groups, respectively (p=ns). Average post-operative hospitalization lasted 5.2 days in the H group compared to 5.4 days in the control group (p=ns).ConclusionsThe 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.

Potential application of Harmonic Scalpel in Laparoscopic Cholecystectomy as an alternative to Monopolar electrocautery

“…However, the lower risk was not statistically or clinically significant in these studies. [15][16][17] This study results reaffirmed that the use of conventional Monopolar electrocautery was not associated with a significantly higher risk of open conversion. The major factors contributing to LC conversion to laparotomy includes laparoscopic difficulty or gallbladder perforation caused by adhesion, uncontrollable bleeding, bile leak, missed coexisting bile duct stones, or gallbladder cancer on preoperative assessment.…”

Harmonic Scalpel versus Monopolar Electrocauterization in Cholecystectomy

“… 18 , 20 However, Bulus et al 21 reported in 60 patients who underwent LC with the Harmonic scalpel, bipolar vessel sealing, and monopolar electrocautery that the use of any of these 3 surgical dissection or coagulation instruments was not associated with a clinically significant increase or reduction in mean operative time (33 ± 10 vs 32 ± 11 vs 37 ± 10 min, respectively). Catena et al 12 further showed in a prospective, randomized, single-center study regarding LC for acute cholecystitis that the Harmonic scalpel or electrocautery techniques had similar mean operative times (101.3 vs 106.4 min; P > .05). This inconsistency in the operative time may be the result of variations in the study protocol, patient selection, operative technique, surgeon's experience, and case volume.…”

“…According to several studies, the Harmonic scalpel is an effective and safe alternative to monopolar electrocautery for hemobiliary stasis in LC. 9 – 12 The major advantage of using the Harmonic scalpel in LC over that of conventional monopolar electrocautery is the reduction in operative time. The Harmonic scalpel allows dissection and closure of the cystic artery and ducts <4–5 mm in diameter without requiring clipping (reported by Husceret al 16 in 1999 and certified by the US Federal Food and Drug Administration in 2006), accounting for the reduction in operative time.…”

“…Results of studies have suggested either statistically significant or clinically limited advantages of using the Harmonic scalpel over electrocauterization. 9 – 12 The primary objective of this study was to evaluate the effectiveness and the safety of Harmonic scalpel, an advanced laparoscopic technique associated with less thermal damage in LC when compared to electrocautery.…”

Einführung der Gefäßversiegelung in einem Schilddrüsenzentrum: Risiken und wirtschaftlicher Nutzen

“…Dies beeinflusst in einem erheblichen Maße die Operationsdauer. Daher werden aufwendige Gefäßligaturen seit einigen Jahren zunehmend durch moderne Methoden der Gefäßversiegelung ersetzt [3][4][5][6]. Momentan kommen hier vorwiegend 2 Geräte zum Einsatz: Das LigaSure™ der Firma Medtronic und das Ultracision™ (Focus Harmonic scalpel™) der Firma Ethicon.…”