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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
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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
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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)