Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT00746850 | Completed

• 1 other identifier: HAC Trial
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholecystitis

Keywords

acute cholecystitis; laparoscopic cholecystectomy; conversion rate; morbidity; mortality; postoperative pain; hospital stay

Outcome Measures

Primary Outcomes (7)

• conversion rate

  1 day

• operative time

  1 day

• mortality

  6-months

• morbidity

  6-months

• hospital stay

  at discharge

• postoperative pain

  postoperatively

• return to daily activities

  6-months

Study Arms (2)

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)

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)

Interventions

early LC within 72 hours after the diagnosis with H (Harmonic) PROCEDURE

early laparoscopic cholecystectomy within 72 hours after the diagnosis of acute cholecystitis with H (Harmonic scalpel)

H

early LC within 72 hours after the diagnosis with MD (Monopolar Diathermy) PROCEDURE

early laparoscopic cholecystectomy within 72 hours after the diagnosis of acute cholecystitis with MD (Monopolar Diathermy)

MD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

S.Orsola-Malpighi University Hospital - University of Bologna

Bologna, 40138, Italy

Location

Related Publications (7)

• 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. doi: 10.1002/bjs.4836.

  PMID: 15584058 BACKGROUND

• Nuzzo G, Giuliante F, Persiani R. [The risk of biliary ductal injury during laparoscopic cholecystectomy]. J Chir (Paris). 2004 Nov;141(6):343-53. doi: 10.1016/s0021-7697(04)95358-6. French.

  PMID: 15738842 BACKGROUND

• 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. doi: 10.1002/bjs.5042. No abstract available.

  PMID: 15782391 BACKGROUND

• 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. doi: 10.1089/109264204322973844.

  PMID: 15107216 BACKGROUND

• 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. doi: 10.1016/s1091-255x(03)00065-9.

  PMID: 12850677 BACKGROUND

• Huscher 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. doi: 10.1007/s00464-002-9068-3. Epub 2002 Oct 29.

  PMID: 12399846 BACKGROUND

• 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. doi: 10.1186/1745-6215-10-34.

  PMID: 19470152 DERIVED

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute; Pain, Postoperative

Interventions

Protons

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Fausto Catena, M.D. PhD

  S.Orsola-Malpighi University Hospital - University of Bologna

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 4, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2010
• Last Updated: October 13, 2011

Record last verified: 2008-09

Locations

IT (1)