Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis (HAC)
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|ClinicalTrials.gov Identifier: NCT00746850|
Recruitment Status : Completed
First Posted : September 4, 2008
Last Update Posted : October 13, 2011
In the developmental stage of laparoscopic cholecystectomy it was considered 'unsafe' or 'technically difficult' to perform laparoscopic cholecystectomy for acute cholecystitis. 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® (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.
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.
Aim of this RCT is to demonstrate that H can reduce conversion rate compared to MD in LC for AC.
|Condition or disease||Intervention/treatment||Phase|
|Cholecystitis||Procedure: early LC within 72 hours after the diagnosis with H (Harmonic) Procedure: early LC within 72 hours after the diagnosis with MD (Monopolar Diathermy)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized, Double-blind, Controlled Trial of Harmonic(H) Versus Monopolar Diathermy (M) for Laparoscopic Cholecystectomy (LC) for Acute Cholecystitis (AC) in Adults.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2010|
early LC within 72 hours after the diagnosis with H (Harmonic)
Procedure: early LC within 72 hours after the diagnosis with H (Harmonic)
early laparoscopic cholecystectomy within 72 hours after the diagnosis of acute cholecystitis with H (Harmonic scalpel)
Active Comparator: MD
early LC within 72 hours after the diagnosis with MD (Monopolar Diathermy)
Procedure: early LC within 72 hours after the diagnosis with MD (Monopolar Diathermy)
early laparoscopic cholecystectomy within 72 hours after the diagnosis of acute cholecystitis with MD (Monopolar Diathermy)
- conversion rate [ Time Frame: 1 day ]
- operative time [ Time Frame: 1 day ]
- mortality [ Time Frame: 6-months ]
- morbidity [ Time Frame: 6-months ]
- hospital stay [ Time Frame: at discharge ]
- postoperative pain [ Time Frame: postoperatively ]
- return to daily activities [ Time Frame: 6-months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746850
|S.Orsola-Malpighi University Hospital - University of Bologna|
|Bologna, Italy, 40138|
|Study Director:||Fausto Catena, M.D. PhD||S.Orsola-Malpighi University Hospital - University of Bologna|
|Principal Investigator:||Luca Ansaloni, M.D.||S.Orsola-Malpighi University Hospital - University of Bologna|
|Principal Investigator:||Salomone Di Saverio, M.D.||S. Orsola Malpighi University Hospital - Maggiore Hospital, Bologna|