NCT02820831

Brief Summary

A prospective observational cohort study to assess the predictive value of preoperative frailty on postoperative quality of life in peripheral vascular surgery patients.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 9, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 1, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

4.7 years

First QC Date

June 29, 2016

Last Update Submit

September 30, 2021

Conditions

Quality of Life

Keywords

Frail ElderlyPeripheral Vascular SurgeryRisk AssessmentFunctional status

Outcome Measures

Primary Outcomes (1)

  • Quality of Life

    Assessed by Medical Outcomes Study Short Form-36 (SF-36)

    12 months after surgery

Secondary Outcomes (5)

  • Quality of Life

    3 months after surgery

  • Walking Impairment

    3 and 12 months after surgery

  • Psychosocial or physical functioning

    3 and 12 months after surgery

  • Incidence of postoperative complications and mortality

    30 days after surgery

  • Length of in-hospital stay

    Post-surgical. The expected length of stay is 5-7 days

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients planned for elective vascular surgery of the lower limb or amputation including surgical procedured combined with endovascular.

You may qualify if:

  • Aged 70 years or older
  • Mentally competent
  • Planned peripheral vascular surgery of the lower limb (femoral artery desobstruction, bypass surgery, amputation), possibly combined with endovascular procedure
  • Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Antonius hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples are taken directly after induction of anesthaesia. Plasma is stored in frozen aliquots at - 80 degrees Celcius.

Study Officials

  • Peter G Noordzij, MD, PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr. P.G. Noordzij

Study Record Dates

First Submitted

June 29, 2016

First Posted

July 1, 2016

Study Start

June 9, 2016

Primary Completion

February 2, 2021

Study Completion

February 2, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Locations

NL(1)