NCT01139385

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 17, 2015

Status Verified

December 1, 2013

Enrollment Period

6.1 years

First QC Date

June 2, 2010

Last Update Submit

March 13, 2015

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • effectiveness closure of the cystic duct

    the effectiveness closure of the cystic duct is assessed on the presence or not of cystic duct bile leak

    at 1 months

Secondary Outcomes (2)

  • postoperative complication

    1 month

  • efficacy and safety of the use of harmonic scalpel performing cholecystectomy

    24 hours

Study Arms (2)

clipless

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

Procedure: Harmonic scalpel

traditional

laparoscopic cholecystectomy performed by harmonic scalpel with closure of the cystic duct only by titanium clip

Procedure: Traditional

Interventions

Harmonic scalpelPROCEDURE

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

clipless
TraditionalPROCEDURE

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

traditional

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with gallstone undergoing cholecystectomy in day surgery setting

You may qualify if:

  • Symptomatic Cholelithiasis
  • Age under 65 yr old
  • BMI under 35
  • ASA I or II

You may not qualify if:

  • Acute cholecystitis
  • Suspect of common bile duct stones

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Rome, Italy, 00189, Italy

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reserch Fellows

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 8, 2010

Study Start

January 1, 2008

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 17, 2015

Record last verified: 2013-12

Locations

IT(1)