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

This study is currently recruiting participants.
Verified January 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Saverio Mari, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01139385
First received: June 2, 2010
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Cholelithiasis
 Procedure: Harmonic scalpel
Procedure: Traditional

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • effectiveness closure of the cystic duct [ Time Frame: at 1 months ] [ Designated as safety issue: Yes ]
    the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak


Secondary Outcome Measures:
  • postoperative complication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    the presence of postoperative complication is investigated

  • efficacy and safety of the use of harmonic scalpel performing cholecystectomy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
clipless
laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device
 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
laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip
 Procedure: 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

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients with gallstone undergoing cholecystectomy in day surgery setting

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139385

Contacts
Contact: Francesco Saverio Mari, MD 00390633776020 frasavmari@yahoo.it

Locations
Italy
Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome Recruiting
Rome, Italy, 00189
Contact: Antonio Brescia, MD     00390633775972     antonio.brescia@uniroma1.it    
Principal Investigator: Francesco Saverio Mari, MD            
Principal Investigator: Luigi Masoni, MD            
Sub-Investigator: Giuseppe R Nigri, MD            
Sub-Investigator: Andrea Milillo, MD            
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Francesco Saverio Mari, Reserch Fellows, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01139385     History of Changes
Other Study ID Numbers: DS-001
Study First Received: June 2, 2010
Last Updated: January 14, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
 Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 21, 2013