Skip to main content
OpenTrials
Completed

NCT Number: NCT01139385

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholelithiasis Biliary Tract Diseases Digestive System Diseases

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Rome, Italy, 00189

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Harmonic scalpel

Procedure

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

traditional

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Acronym: CLCHS

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jun 8, 2010
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.