Morbimortality in Older Patients Undergoing Urgent Abdomi... | NCT03205384

Studies
Morbimortality in Older Patients Undergoing Urgent Abdominal Surgery

NCT03205384

Sponsor

Hospital of Navarra

Status

Completed

Last Update Posted

Mar 24, 2020Actual

Enrollment

500Actual

Phase

Not provided

Conditions

Surgery--Complications

Interventions

surgery

Countries

Spain

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

Mar 2020

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

Jan 2017Actual

Primary Completion Date

Jun 2019Actual

Completion Date

Jun 2019Actual

First Submitted Date

Feb 22, 2017

First Submission Date that Met QC Criteria

Jun 29, 2017

First Posted Date

Jul 2, 2017Actual

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

Mar 22, 2020

Last Update Posted Date

Mar 24, 2020Actual

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

Morbimortality in older patients undergoing abdominal surgery.

Detailed Description

The aim of this study is to validate the modified CriSTAL tool for 30 mortality in elderly patients undergoing urgent abdominal surgery. To provide a new tool that could be used in conjunction with clinical judgment to aid in decision-making.

The second objective of our study was to assess the quality of life, frailty, functional status and nutritional status in elderly patients that survive six months after an urgent abdominal surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
surgical management		Patient older than 65 years old, undergoing urgent abdominal surgery in our center	Procedure: surgery
not surgical management		Patients that presents a surgical disease, but we desestimate surgical procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery	Procedure		surgical management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Barthel index, questionnaire	to measure performance in activities of daily living	6 months

Secondary Outcomes

Measure	Description	Time Frame
Clavien- Dindo Modified	Morbimortality using Clavien-Dindo classification	1 year

Other Outcomes

Measure	Description	Time Frame
FRAIL scale, Fried score	To measure frailty	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>65 years old, accepted in emergency department

Exclusion Criteria:

not sign the consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

110 Years

Standard Ages

Older Adult

Study Population

patiens>65 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
javier Herrera, doctor	UPNA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPNA		Pamplona	Navarre	31008	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000073496	Frailty

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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