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

This study is ongoing, but not recruiting participants.
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: December 10, 2013
Last verified: December 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: December 10, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014