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

NCT ID: NCT01139385

Last Updated: 2015-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

218 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2014-02-28

Brief Summary

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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

Detailed Description

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Conditions

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Cholelithiasis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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clipless

laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device

Harmonic scalpel

Intervention Type PROCEDURE

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

Traditional

Intervention Type PROCEDURE

The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips

Interventions

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Harmonic scalpel

The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Saverio Mari

Reserch Fellows

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oneday - Day Surgery Unit - Azienda Ospedaliera Sant'Andrea - University Sapienza of Rome

Rome, Italy, Italy

Site Status

Countries

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Italy

Other Identifiers

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DS-001

Identifier Type: -

Identifier Source: org_study_id

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