Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis - Full Text View

Sponsor:	University of Bologna
Information provided by:	University of Bologna
ClinicalTrials.gov Identifier:	NCT00746850

Purpose

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
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.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

U.S. FDA Resources

Further study details as provided by University of Bologna:

Primary Outcome Measures:

conversion rate [ Time Frame: 1 day ] [ Designated as safety issue: No ]
operative time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
mortality [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
morbidity [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]
hospital stay [ Time Frame: at discharge ] [ Designated as safety issue: No ]
postoperative pain [ Time Frame: postoperatively ] [ Designated as safety issue: No ]
return to daily activities [ Time Frame: 6-months ] [ Designated as safety issue: No ]

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
H: Experimental 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)
MD: Active Comparator 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)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients (>18 years)
Clinical (pain, fever > 37.5 °C, WBC > 10.000 / microL), and ultrasound evidence of cholecystitis
ASA I-III patients
Informed consent
Less than 72h from the onset

Exclusion Criteria:

Informed consent refusal
Choledocholithiasis
Generalized peritonitis
Previous abdominal surgical procedures
Patients with an intra-operative findings of different pathology will be excluded from the study
Apache II score > 10

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746850

Contacts

Contact: Fausto Catena, MD PhD	+390516363235	fausto.catena@aosp.bo.it
Contact: Luca Ansaloni, MD		lansaloni@aosp.bo.it

Locations

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.

Sponsors and Collaborators

University of Bologna

Investigators

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

More Information

Publications:

Johansson M, Thune A, Nelvin L, Stiernstam M, Westman B, Lundell L. Randomized clinical trial of open versus laparoscopic cholecystectomy in the treatment of acute cholecystitis. Br J Surg. 2005 Jan;92(1):44-9.

Nuzzo G, Giuliante F, Persiani R. [The risk of biliary ductal injury during laparoscopic cholecystectomy.] J Chir (Paris). 2004 Nov;141(6):343-53. Review. French.

Rai R, Sinha A, Rai S. Randomized clinical trial of open versus laparoscopic cholecystectomy in the treatment of acute cholecystitis (Br J Surg 2005; 92: 44-49). Br J Surg. 2005 Apr;92(4):494. No abstract available.

Asoglu O, Ozmen V, Karanlik H, Igci A, Kecer M, Parlak M, Unal ES. Does the complication rate increase in laparoscopic cholecystectomy for acute cholecystitis? J Laparoendosc Adv Surg Tech A. 2004 Apr;14(2):81-6.

Johansson M, Thune A, Blomqvist A, Nelvin L, Lundell L. Management of acute cholecystitis in the laparoscopic era: results of a prospective, randomized clinical trial. J Gastrointest Surg. 2003 Jul-Aug;7(5):642-5.

Hüscher CG, Lirici MM, Di Paola M, Crafa F, Napolitano C, Mereu A, Recher A, Corradi A, Amini M. Laparoscopic cholecystectomy by ultrasonic dissection without cystic duct and artery ligature. Surg Endosc. 2003 Mar;17(3):442-51. Epub 2002 Oct 29.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Catena F, Ansaloni L, Di Saverio S, Gazzotti F, Coccolini F, Pinna AD. 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 May 26;10:34.

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 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by University of Bologna:

acute cholecystitis
laparoscopic cholecystectomy
conversion rate
morbidity

mortality
postoperative pain
hospital stay

Additional relevant MeSH terms:

Gallbladder Diseases
Digestive System Diseases
Cholecystitis, Acute

Acalculous Cholecystitis
Biliary Tract Diseases
Cholecystitis

ClinicalTrials.gov processed this record on February 08, 2010