Novel Preoperative Score Predicting Outcome Following Liv... | NCT01003197

Studies
Novel Preoperative Score Predicting Outcome Following Liver Resection

NCT01003197

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Oct 28, 2009Estimated

Enrollment

Not provided

Phase

Not provided

Conditions

Serious Complications Following Liver Resection

Interventions

Not provided

Countries

Switzerland

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 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

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

Oct 27, 2009

Last Update Posted Date

Oct 28, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.

Detailed Description

Liver surgery is associated with a substantial rate of complications. Early identification of patients at risk of serious complications is important in order to adapt therapeutic strategies and to improve quality. The purpose of this study is to develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.

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

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.		postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>= 18 years
liver resection

Exclusion Criteria:

Trauma cases

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

HPB center Zurich, Switzerland

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Breitenstein, Dr. med.	Department of Visceral and Transplantation Surgery, University Hospital of Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Visceral and Transplantation Surgery, University Hospital of Zurich		Zurich	Canton of Zurich	8091	Switzerland

Label	Type	Description	Intervention Names
complication group < III
complication group >= III