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Surgery in Persons of Older Age

NCT01924585 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2015-03-26

No results posted yet for this study

Summary

Surgery in persons of older AGE (SAGE) is an observational study of patients aged 60 years and older undergoing major colorectal surgery. That is to say we are looking at how older patients recovery following surgery, and that patients who volunteer to take part will absolutely not have any changes made to patients planned treatment or surgery.

Patients (identified by their Consultant) will be asked if they would like to participate in the study, agreeing to undertake an additional questionnaire, blood test, provide a urine specimen and several basic physical tests during the pre-assessment visit taking an additional 30-45 minutes.

This will not affect their treatment in any way. Participation is voluntary.

At the time of the pre-assessment process the patient will then be approached by a researcher, who will explain the study in more detail and obtain written consent.

The questionnaire is a combination of questions, which have been used in other similar studies and may be used to identify people who are fitter than others to undergo surgery. These questions are not too dissimilar to those that may be asked during the pre-assessment process. In fact some hospitals use some of these questions (but not usually all) routinely during a hospital admission process.

Several basic physical tests will be performed: hand grip strength test and some basic walking and chair rising tests. These will be supervised by the trained researcher to ensure they are carried out safely.

A small blood sample (20ml) will be obtained, ideally at the same time as blood is taken for the standard pre-operative assessment process. We will also take urine specimens. The blood sample and urine specimens will be saved for tests later. There are several potential blood and urine tests that may be related to physical frailty/impairment and the aging process.

The patient will undergo surgery as planned and be discharged from hospital. No researcher will interfere with the planned care or conduct any data collection at this point.

At approximately 1. 3, 6 and 12 months following surgery the patient will be asked to complete the questionnaire either in person, by phone or mail. If reviewed in a clinic at the time of their postoperative follow-up checks, then we will repeat the basic physical tests again also.

The patient's notes will be reviewed by a researcher (who is also a doctor) to see what operation was performed, the length of hospital stay, and if any problems developed. The patients GP may also be contacted if additional information is required.

This study, while based on several others, is the first of its kind to see how persons recover after surgery being assessed over one year.

We will recruit for 18 months across two hospitals aiming to recruit 200 patients during this time.

Conditions

  • Colorectal Disorders
  • Surgery
  • Old Age; Debility
  • Quality of Life
  • Complications

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Nigel M Bagnall, MBChB MRCS · Imperial College London

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2015-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01924585 on ClinicalTrials.gov