Cholelithiasis
Conditions
Brief summary
The aim of this study was to compare between the safety and efficacy of the harmonic shears and the commonly used clip technique in achieving safe closure and division of the cystic duct in the laparoscopic cholecystectomy in day surgery setting
Interventions
PROCEDUREHarmonic scalpel
The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery
PROCEDURETraditional
The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips
Sponsors
University of Roma La Sapienza
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic Cholelithiasis * Age under 65 yr old * BMI under 35 * ASA I or II
Exclusion criteria
* Acute cholecystitis * Suspect of common bile duct stones
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effectiveness closure of the cystic duct | at 1 months | the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative complication | 1 month | the presence of postoperative complication is investigated |
| efficacy and safety of the use of harmonic scalpel performing cholecystectomy | 24 hours | the efficacy and safety of the use of harmonic scalpel performing cholecystectomy is assessed by evaluating the operative time, the presence of major or minor intraoperative complication and the postoperative complication. |
Countries
Italy
Outcome results
None listed