Analysis of Palliative Surgery in View of Quality of Life... | NCT00690391

Studies
Analysis of Palliative Surgery in View of Quality of Life and Prognosis

NCT00690391

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Jun 4, 2008Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Cancer
Quality of Life

Interventions

Not provided

Countries

Germany

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

May 2008

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

May 2008

Primary Completion Date

May 2009Estimated

Completion Date

May 2013Estimated

First Submitted Date

May 30, 2008

First Submission Date that Met QC Criteria

May 30, 2008

First Posted Date

Jun 4, 2008Estimated

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

May 30, 2008

Last Update Posted Date

Jun 4, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to define if palliative surgery in patients with cancer improves quality of life and prognosis.

Detailed Description

The purpose of this study is to find out if palliative surgery in patients with cancer improves quality of life and prognosis. There will be a scheduled assessment of quality of life and assessment of postoperative complications. prognostic scoring will be performed before surgical intervention.

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

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical observation		patients with cancer in a palliative setting and in need of surgical interventions

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinical diagnosis of inoperable cancer
planned surgery
able to give interview
written informed consent

Exclusion Criteria:

unconsciousness
psychiatric disorder
not able to communicate in German

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with plannes surgery and cancer in he University hospital Frankfurt

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Wullstein, PD Dr.	Contact	+49696301	83563	Christoph.Wullstein@kgu.de

Overall Officials

Name	Affiliation	Role
Christoph Wullstein, PD DR.	Goethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Frankfurt	Recruiting	Frankfurt		60590	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided