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Sponsored by: |
University of Bologna |
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Information provided by: | University of Bologna |
ClinicalTrials.gov Identifier: | NCT00746850 |
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 | Intervention |
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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) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Controlled Trial of Harmonic(H) Versus Monopolar Diathermy (M) for Laparoscopic Cholecystectomy (LC) for Acute Cholecystitis (AC) in Adults. |
Estimated Enrollment: | 42 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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H: Experimental
early LC within 72 hours after the diagnosis with H (Harmonic)
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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)
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MD: Active Comparator
early LC within 72 hours after the diagnosis with MD (Monopolar Diathermy)
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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)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Fausto Catena, MD PhD | +390516363235 | fausto.catena@aosp.bo.it |
Contact: Luca Ansaloni, MD | lansaloni@aosp.bo.it |
Italy | |
S.Orsola-Malpighi University Hospital - University of Bologna | Recruiting |
BOLOGNA, Italy, 40138 | |
Contact: Fausto Catena, M.D. PhD +390516363235 fausto.catena@aosp.bo.it | |
Contact: Luca Ansaloni, M.D. lansaloni@aosp.bo.it | |
Principal Investigator: Fausto Catena, M.D. PhD | |
Principal Investigator: Luca Ansaloni, M.D. | |
Principal Investigator: Giorgio Ercolani, M.D. | |
Sub-Investigator: Filippo Gazzotti, M.D. | |
Sub-Investigator: Federico Coccolini, M.D. | |
Principal Investigator: Salomone Di Saverio, M.D. | |
Principal Investigator: Antonio Daniele Pinna, M.D. PhD | |
Sub-Investigator: Luigi D'Alessandro, M.D. |
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 |
Responsible Party: | S.Orsola-Malpighi University Hospital ( Dr. Fausto Catena MD PhD ) |
Study ID Numbers: | HAC Trial |
Study First Received: | September 3, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00746850 |
Health Authority: | Italy: Ethics Committee |
acute cholecystitis laparoscopic cholecystectomy conversion rate morbidity |
mortality postoperative pain hospital stay |
Gallbladder Diseases Digestive System Diseases Cholecystitis, Acute Acalculous Cholecystitis |
Biliary Tract Diseases Cholecystitis Pain Pain, Postoperative |