Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery

Completed

• Conditions: Cholelithiasis
• Interventions: Procedure: Harmonic scalpel; Procedure: Traditional

• Registration Number: NCT01139385
• Lead Sponsor: University of Roma La Sapienza

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Status Verified: 2013-12
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
clipless	Harmonic scalpel	laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device
traditional	Traditional	laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
postoperative complication	1 month	the presence of postoperative complication is investigated

Trial Locations

Locations (1)

Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome; 🇮🇹 Rome, Italy