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

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

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

ClinicalTrials.gov processed this record on March 03, 2015

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