Overview

This trial is active, not recruiting.

Condition cholelithiasis
Treatments harmonic scalpel, traditional
Sponsor University of Roma La Sapienza
Start date January 2008
End date February 2014
Trial size 200 participants
Trial identifier NCT01139385, DS-001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
laparoscopic cholecystectomy performed by harmonic scalpel with closure and division of the cystic duct only by the device
harmonic scalpel
The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery
laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip
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

Primary Outcomes

Measure
effectiveness closure of the cystic duct
time frame: at 1 months

Secondary Outcomes

Measure
postoperative complication
time frame: 1 month
efficacy and safety of the use of harmonic scalpel performing cholecystectomy
time frame: 24 hours

Eligibility Criteria

Male or female participants up to 65 years old.

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

Additional Information

Official title Comparative Study Between Clipless Laparoscopic Cholecystectomy Using Harmonic Scalpel Versus Conventional Method in Day Surgery: a Prospective Randomized Study
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by University of Roma La Sapienza.