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

March 13, 2015 updated by: Francesco Saverio Mari, University of Roma La Sapienza

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00189
        • Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 65 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with gallstone undergoing cholecystectomy in day surgery setting

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complication
Time Frame: 1 month
the presence of postoperative complication is investigated
1 month
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

June 7, 2010

First Posted (ESTIMATE)

June 8, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 13, 2015

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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