NCT03205384

Brief Summary

Morbimortality in older patients undergoing abdominal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

2.4 years

First QC Date

February 22, 2017

Last Update Submit

March 22, 2020

Conditions

Surgery--Complications

Keywords

Urgent abdominal surgery. Quality of life, functional status, frailty, nutritional status

Outcome Measures

Primary Outcomes (1)

  • Barthel index, questionnaire

    to measure performance in activities of daily living

    6 months

Secondary Outcomes (1)

  • Clavien- Dindo Modified

    1 year

Other Outcomes (1)

  • FRAIL scale, Fried score

    6 months

Study Arms (2)

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

surgeryPROCEDURE
surgical management

Eligibility Criteria

Age65 Years - 110 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

patiens\>65 years old

You may qualify if:

  • \>65 years old, accepted in emergency department

You may not qualify if:

  • not sign the consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPNA

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Frailty

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • javier Herrera, doctor

    UPNA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 22, 2017

First Posted

July 2, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)