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

Cholelithiasis Clinical Trial

— CLCHS  

Official title:

Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139385
• Other study ID #: DS-001
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: March 13, 2015
• Start date: January 2008
• Est. completion date: February 2014

Study information

• Verified date: December 2013
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 65 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Harmonic scalpel
The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery
• Traditional
The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips

Locations

Country	Name	City	State
Italy	Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effectiveness closure of the cystic duct	the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak	at 1 months	Yes
Secondary	postoperative complication	the presence of postoperative complication is investigated	1 month	Yes
Secondary	efficacy and safety of the use of harmonic scalpel performing cholecystectomy	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.	24 hours	Yes