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Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis

NCT00746850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-10-13

No results posted yet for this study

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

Interventions

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)

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)

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Principal Investigators

  • Fausto Catena, M.D. PhD · S.Orsola-Malpighi University Hospital - University of Bologna

  • Luca Ansaloni, M.D. · S.Orsola-Malpighi University Hospital - University of Bologna

  • Salomone Di Saverio, M.D. · S. Orsola Malpighi University Hospital - Maggiore Hospital, Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-11-30
Completion
2010-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00746850 on ClinicalTrials.gov