Laparoscopic Liver Resection | NCT00553033

Studies
Laparoscopic Liver Resection

NCT00553033

Sponsor

IRCCS San Raffaele

Status

Unknown status

Last Update Posted

Nov 2, 2007Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Tumors

Interventions

Laparoscopic liver surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Nov 1, 2007

First Submission Date that Met QC Criteria

Nov 1, 2007

First Posted Date

Nov 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2007

Last Update Posted Date

Nov 2, 2007Estimated

Description Module

Brief Summary

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

Detailed Description

Perioperative course of patients undergoing liver resection is evaluated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Procedure: Laparoscopic liver surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic liver surgery	Procedure	Ultrasonic dissector, harmonic scalpel	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Perioperative Morbidity and mortality		Perioperative

Secondary Outcomes

Measure	Description	Time Frame
Patient satisfation		Perioperative
Patients satisfaction		Postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

benign or malignant tumors
tumor size less than 12 cm

Exclusion Criteria:

Operations that required laparotomic procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients udergoing liver resection for benign or malignant tumors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luca Aldrighetti, M.D, PhD	Contact	390226437806		aldrighetti.luca@hsr.it

Overall Officials

Name	Affiliation	Role
Luca Aldrighetti, M.D PhD	Department of Surgery - Liver Unit, Scientific Institute San Raffaele	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery - Liver Unit, Scientific Institute San Raffaele	Recruiting	Milan	Milan	20132	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17701265	Result	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. 2008 Mar;12(3):457-62. doi: 10.1007/s11605-007-0244-6. Epub 2007 Aug 14.