Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.

May 25, 2018 updated by: Shrikant Pande, Changi General Hospital

Prognosticating Outcomes in Stroke, Acquired Brain Injury, Amputee and Other Neurological Impairments

This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.

Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.

Study Type

Observational

Enrollment (Actual)

73

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.

Description

Inclusion Criteria:

Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria:

Exclusion Criteria:

Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival in relation to time
Time Frame: 6 months to 6 years
Survival outcomes were analysed and have been included in the results.
6 months to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2016

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

May 25, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

May 29, 2018

Last Update Submitted That Met QC Criteria

May 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 201511-00072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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