Clinical Trial: Harmonic in Laparoscopic Cholecystectomy for Acute Cholecystitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized, Double-blind, Controlled Trial of Harmonic(H) Versus Monopolar Diathermy (M) for Laparoscopic Cholecystectomy (LC) for Acute Cholecystitis (AC) in Adults.

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.


Detailed Summary:

DESIGN

The study project is a prospective, randomized investigation. The study will be performed in the Department of Emergency Surgery St Orsola-Malpighi University Hospital (Bologna, Italy), a large teaching institutions, with the participation of all surgeons who accept to be involved in.

The patients will be divided in two groups: in the first group the patient will be submitted to early LC within 72 hours after the diagnosis with H while in the second group will be submitted to early LC within 72 hours with MD.

HOW RANDOMIZED

The randomization will be obtained through computer-generated schedule. The result of this randomization will be sealed in numbered envelopes. After cholecystitis diagnosis if the patient fulfils the inclusion criteria the responsible surgeon will ask the patient to participate to the study. If the patient agree, he/ she will sign the informed consent. After patient's consent the randomization will be carried out. The responsible surgeon will record the patient name (and number).

All eligible patients will be recorded.

STATISTICS

POWER CALCULATIONS:

Sample size has been calculated to reach a confidence level of 95% with a power of 80%.A sample size of 42 patients is calculated supposing that the hospital stay for LC with H the conversion rate can be reduced from 35% to 3%. The sample size will be 21 patients for each group (42 patients for the whole study).For comparison of the two groups, chi-square analysis and Fisher's exact test are used when appropriate for qualitative data, and the Student t-test
Sponsor: University of Bologna

Current Primary Outcome:

  • conversion rate [ Time Frame: 1 day ]
  • operative time [ Time Frame: 1 day ]
  • mortality [ Time Frame: 6-months ]
  • morbidity [ Time Frame: 6-months ]
  • hospital stay [ Time Frame: at discharge ]
  • postoperative pain [ Time Frame: postoperatively ]
  • return to daily activities [ Time Frame: 6-months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Bologna

Dates:
Date Received: September 3, 2008
Date Started: September 2008
Date Completion:
Last Updated: October 12, 2011
Last Verified: September 2008