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

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ClinicalTrials.gov Identifier: NCT01139385
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):
Francesco Saverio Mari, University of Roma La Sapienza

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment
Cholelithiasis Procedure: Harmonic scalpel Procedure: Traditional

Study Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 218 participants
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
Study Start Date : January 2008
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. effectiveness closure of the cystic duct [ Time Frame: 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 :
  1. postoperative complication [ Time Frame: 1 month ]
    the presence of postoperative complication is investigated

  2. efficacy and safety of the use of harmonic scalpel performing cholecystectomy [ Time Frame: 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.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139385


Locations
Italy
Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome
Rome, Italy, 00189
Sponsors and Collaborators
University of Roma La Sapienza
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: June 8, 2010    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: December 2013

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