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

Fausto Catena; Salomone Di Saverio; Luca Ansaloni; Federico Coccolini; Massimo Sartelli; Carlo Vallicelli; Michele Cucchi; Antonio Tarasconi; Rodolfo Catena; GianLuigi De' Angelis; Hariscine Keng Abongwa; Daniel Lazzareschi; Antonio Pinna

doi:10.1186/1749-7922-9-53

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

World J Emerg Surg. 2014 Oct 20;9(1):53. doi: 10.1186/1749-7922-9-53. eCollection 2014.

Affiliations

¹ Department of Emergency Surgery, Parma University Hospital, Parma, Italy.
² St. Orsola - Malpighi University Hospital, Bologna, Italy.
³ Bergamo Hospital, Bergamo, Italy.
⁴ Macerata Hospital, Macerata, Italy.

Abstract

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<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).

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.

Keywords: Acute cholecystitis; Biliary surgery; CBD complications; Conversion rate; Harmonic scalpel; Laparoscopic cholecistectomy; Randomized controlled trial; Safety.