Evaluation of Surgical Risk in Elderly Patients Submitted... | NCT00672698

Studies
Evaluation of Surgical Risk in Elderly Patients Submitted to Elective Surgery

NCT00672698

Sponsor

Cirujanos la Serena

Status

Withdrawn

Last Update Posted

Oct 31, 2012Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

PERIPHERAL VASCULAR DISEASES
Digestive Diseases
BILIARY TRACT DISEASES

Interventions

SURGERY

Countries

Chile

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 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

NOT ENOUGH DATA AVAILABLE

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

May 2, 2008

First Submission Date that Met QC Criteria

May 2, 2008

First Posted Date

May 6, 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

Oct 29, 2012

Last Update Posted Date

Oct 31, 2012Estimated

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 establish the surgical risk factors and differences between different diseases in elderly patients submitted to elective surgery in our institution.

Detailed Description

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
I	VASCULAR SURGERY	Procedure: SURGERY
II	DIGESTIVE SURGERY	Procedure: SURGERY
III	BILIARY TRACT SURGERY	Procedure: SURGERY

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SURGERY	Procedure	ELECTIVE SURGICAL PROCEDURES	I II III

Measure	Description	Time Frame
Mortality		1 YEAR

Measure	Description	Time Frame
Morbidity		1 MONTH

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients older than 65 years of age
All necessary data to calculate p-possum and saps II

Exclusion Criteria:

Patients with incomplete data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients older than 65 years of age submitted to elective surgery at our institution

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marceloa A Beltran, M.D.	Hospital de La Serena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital De La Serena		La Serena	Coquimbo Region		Chile

Condition Browse Module

MeSH Terms

ID	Term
D016491	Peripheral Vascular Diseases
D004066	Digestive System Diseases
D001660	Biliary Tract Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided