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

Trials, May 2009

Background 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(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. 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. Methods/Design 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. Trial Registration ClinicalTrials.gov Identifier: NCT00746850

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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

Fausto Catena 0 Luca Ansaloni 0 Salomone Di Saverio 0 Filippo Gazzotti 0 Federico Coccolini 0 Antonio Daniele Pinna 0 0 Address: Emergency Surgery Unit, Department of General and Transplant surgery (Prof A. D. Pinna), S. Orsola Malpighi University Hospital , Bologna , Italy Background: 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(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. 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. Methods/Design: 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. Trial Registration: ClinicalTrials.gov Identifier: NCT00746850 - Background In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis [1,2]. 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 [3,4] and common bile duct lesions [5]. 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. H technology reduces the need for ligatures with simultaneous cutting and coagulation: moreover there is not electricity to or through the patient H has a greater precision near vital structures and it produces minimal smoke with improved visibility in the surgical field. [6] 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%). [6] However there are not prospective randomized controlled trials showing the advantages of H compared to Monopolar Diathermy (MD the most commonly used electrical scalpel) in LC. Aim of this RCT is to demonstrate that H can decrease conversion rate compared to MD in LC for AC, without a significant increase of morbidity. Methods The study project is a prospective, randomized investigation. The study will be performed in the Department of Emergency Surgery St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institutions, with the participation of all surgeons who accept to be involved in. The Ethic Committee of St. Orsola Malpighi University Hospital has approved the study protocol on June 24th 2008. The study and its Informed Consent form have been judged by the Committee to be ethically and scientifically satisfactory as well as correct and adequate to the aims. The patients will be allocated in two groups: in the first group the patient will be submitted to early LC within 72 The randomization will be obtained through computergenerated schedule. Blocked randomization is used to ensure close balance of the numbers in each group at any time during the study. The result of this randomization will be sealed in numbered envelopes, inserting inside a cardboard to ensure that they are opaque. After cholecystitis diagnosis if the patient fulfils the inclusion criteria the responsible surgeon will ask the patient to partecipate to the study. If the patient agree, he/she will sign the informed consent. After patient's consent the randomization will be carried out. The responsible surgeon will record the patient name (and number). [7-9] All eligible patients will be recorded. [ (...truncated)


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Fausto Catena, Luca Ansaloni, Salomone Di Saverio, Filippo Gazzotti, Federico Coccolini, Antonio Pinna. 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, Trials, 2009, pp. 34, 10, DOI: 10.1186/1745-6215-10-34