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Laparoscopic Liver Resection

This study is currently recruiting participants.
Verified by IRCCS San Raffaele, October 2007

Sponsored by: IRCCS San Raffaele
Information provided by: IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT00553033
  Purpose

The aim of this study is to evaluate the feasibility and safety of laparoscopic liver surgery.


Condition Intervention
Tumors
 Procedure: Laparoscopic liver surgery

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Prospective
Official Title:   Prospective Evaluation of Laparoscopic Liver Resection

Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • Perioperative Morbidity and mortality [ Time Frame: Perioperative ]

Secondary Outcome Measures:
  • Patient satisfation [ Time Frame: Perioperative ]
  • Patients satisfaction [ Time Frame: Postoperative ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   40
Study Start Date:   September 2005
Estimated Study Completion Date:   December 2008

Groups/Cohorts Assigned Interventions
A Procedure: Laparoscopic liver surgery
Ultrasonic dissector, harmonic scalpel

Detailed Description:

Perioperative course of patients undergoing liver resection is evaluated.

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Patients udergoing liver resection for benign or malignant tumors


Criteria

Inclusion Criteria:

  • benign or malignant tumors
  • tumor size less than 12 cm

Exclusion Criteria:

  • Operations that required laparotomic procedures
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00553033

Contacts
Contact: Luca Aldrighetti, M.D, PhD     390226437806     aldrighetti.luca@hsr.it    

Locations
Italy
Department of Surgery - Liver Unit, Scientific Institute San Raffaele     Recruiting
      Milan, Italy, 20132
      Contact: Luca Aldrighetti, M.D PhD     +39-02-2643-7808     aldrighetti.luca@hsr.it    

Sponsors and Collaborators
IRCCS San Raffaele

Investigators
Study Director:     Luca Aldrighetti, M.D PhD     Department of Surgery - Liver Unit, Scientific Institute San Raffaele    
  More Information


Publications of Results:
Aldrighetti L, Pulitano C, Catena M, Arru M, Guzzetti E, Casati M, Comotti L, Ferla G. A Prospective Evaluation of Laparoscopic Versus Open Left Lateral Hepatic Sectionectomy. J Gastrointest Surg. 2007 Aug 14; [Epub ahead of print]
 

Study ID Numbers:   LPSLIVER1
First Received:   November 1, 2007
Last Updated:   November 1, 2007
ClinicalTrials.gov Identifier:   NCT00553033
Health Authority:   Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
Patients must be candidable to liver resection  

ClinicalTrials.gov processed this record on October 07, 2008

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