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Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis (HAC)

This study has been completed.
Sponsor:
Information provided by:
University of Bologna
ClinicalTrials.gov Identifier:
NCT00746850
First received: September 3, 2008
Last updated: October 12, 2011
Last verified: September 2008
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Controlled Trial of Harmonic(H) Versus Monopolar Diathermy (M) for Laparoscopic Cholecystectomy (LC) for Acute Cholecystitis (AC) in Adults.

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 ]

Enrollment: 42
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H
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)

  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

Locations
Italy
S.Orsola-Malpighi University Hospital - University of Bologna
Bologna, Italy, 40138
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
Principal Investigator: Salomone Di Saverio, M.D. S. Orsola Malpighi University Hospital - Maggiore Hospital, Bologna
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Fausto Catena MD PhD, S.Orsola-Malpighi University Hospital
ClinicalTrials.gov Identifier: NCT00746850     History of Changes
Other Study ID Numbers: HAC Trial
Study First Received: September 3, 2008
Last Updated: October 12, 2011
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:
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
 Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013