Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000045213
Ethics application status
Approved
Date submitted
5/12/2017
Date registered
15/01/2018
Date last updated
2/10/2019
Date data sharing statement initially provided
2/10/2019
Date results information initially provided
2/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of frailty, activity levels and mitochondrial efficiency on post operative outcomes in older patients undergoing abdominal surgery
Scientific title
The relationship between frailty, activity levels and mitochondrial efficiency, and their impact on hospital length of stay and other post operative outcomes in older patients undergoing elective colorectal surgery
Secondary ID [1] 293542 0
nil
Universal Trial Number (UTN)
Trial acronym
The FRAME study (Frailty, activity and Mitochondrial efficiency)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recovery from colorectal surgery
305742 0
Frailty 305743 0
Colorectal cancer 305744 0
Inflammatory bowel disease 305745 0
Diverticulitis 305746 0
Colorectal surgery 305747 0
Condition category
Condition code
Surgery 304961 304961 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This will be an observational study of older patients undergoing elective colorectal surgery.
Patients will be recruited at least two weeks and not more than six months prior to surgery.
Markers of frailty will be assessed preoperatively using three different measures.
1. An edmonton frailty scale score (EFS) will be recorded two weeks prior to scheduled surgery
2. Activity levels (using a step counter) will be measured for 10- 14 days prior to scheduled surgery.
3. A blood test assessing mitochondrial function which has been associated with ageing will be performed at two weeks prior to scheduled surgery.

Other than the assessment of these frailty markers, patients will undergo routine perioperative care.

Post operatively, patients will be followed for 100 days and observed for a number of outcomes (specified further in section 4)

EFS will be repeated on day 30 postoperatively
Mitochondrial function blood test will be repeated on day 2 and day 30 postoperatively
Activity levels will be measured from day 2 postoperatively for 14 - 28 days
Intervention code [1] 299780 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304140 0
Hospital length of stay. This includes time spent in tertiary referral centre (ie site of surgery) and time spent in primary rehabilitation hospital.
Timepoint [1] 304140 0
Day of discharge from rehabilitation hospital
Secondary outcome [1] 341086 0
Discharge destination
Timepoint [1] 341086 0
Day of discharge
Secondary outcome [2] 341087 0
Post operative complications.
- a standardised proforma has been designed for the study that includes surgical and medical complications. This data will be gathered prospectively during the inpatient postoperative stay combined with a review of medical records at 30 and 100 days.
Examples of complications on proforma include
SURGICAL COMPLICATIONS (graded clavien dindo I-V)
surgical site infection
ileus
anastomotic leak
bleeding
return to theatre
other
MEDICAL COMPLICATIONS
CVS (arrest, MI, DVT/PE, arrhythmia requiring intervention)
Respiratory (pneumonia)
Neurological (CVA, acute delirium)
Renal (AKI, UTI, failed TOV)
sepsis
unplanned ICU admission
Timepoint [2] 341087 0
100 days following scheduled surgery
Secondary outcome [3] 341088 0
survival
Timepoint [3] 341088 0
100 days following scheduled surgery
Secondary outcome [4] 341859 0
SF-12 (quality of life)
Timepoint [4] 341859 0
Post operative day 30
Secondary outcome [5] 341860 0
Fatigue (visual analogue scale)
Timepoint [5] 341860 0
Post operative day 30

Eligibility
Key inclusion criteria
Those included in this study will
• Be undergoing an elective colorectal surgical procedure within the next 6 months
• Be aged 65 years or over
• Be ambulatory, including with the use of walking aids such as sticks or frames
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to obtain valid consent
• Stoma reversal surgery
• Non general-surgical abdominal procedures (ie vascular procedures)
• Non-ambulatory/mobilises in wheelchair
• Emergency surgery
• Date of recruitment less than 2 weeks before admission date
• Dermatitis or skin lesions of the upper limb that would prevent safe and comfortable wearing of the activity tracking device
• Regular participation in moderate to high intensity physical activity not detected by activity tracking device, such as cycling or swimming

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Pearson's correlation analysis to assess correlation between different measures of frailty
Multiple regresison analysis to assess relationship between frailty and postoperative outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/12/2017
Date of last participant enrolment
Anticipated
1/10/2019
Actual
3/09/2018
Date of last data collection
Anticipated
20/12/2019
Actual
10/12/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 9412 0
New Zealand
State/province [1] 9412 0
Canterbury

Funding & Sponsors
Funding source category [1] 298156 0
Hospital
Name [1] 298156 0
Christchurch public hospital
Country [1] 298156 0
New Zealand
Primary sponsor type
University
Name
University of Otago Christchurch
Address
2 Riccarton Avenue
Christchurch 8041
Country
New Zealand
Secondary sponsor category [1] 297246 0
None
Name [1] 297246 0
n/a
Address [1] 297246 0
n/a
Country [1] 297246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299171 0
Health and Disability Ethics Committee
Ethics committee address [1] 299171 0
Ministry of Health
133 Molesworth Street
PO box 5013
Wellington 6011
Ethics committee country [1] 299171 0
New Zealand
Date submitted for ethics approval [1] 299171 0
15/08/2017
Approval date [1] 299171 0
28/09/2017
Ethics approval number [1] 299171 0
17/CEN/170

Summary
Brief summary
Older patients who undergo surgery are more likely to have complications and prolonged recovery after their operation. One of the things which can predict recovery after surgery in older patients in frailty. Frailty results from age-related changes and affects people’s ability to tolerate medical treatments, including operations.
This is an observational study which will be looking at older people who are having colorectal surgery. We will measure the frailty of the participants using a frailty assessment tool. We will also measure their daily activity levels with a watch that counts steps, and the function of their mitochondria, which is the part of the cell that produces energy.
We will follow these people after their operation to see how well they recover. We aim to investigate the relationship between frailty, activity levels and the function of the mitochondria, and see if these things are associated with how well patients recover following an operation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79534 0
Dr Simon Richards
Address 79534 0
Department of Surgery
Christchurch Public Hospital
2 Riccarton Avenue
Christchurch 8140
Country 79534 0
New Zealand
Phone 79534 0
+6433640014
Fax 79534 0
Email 79534 0
simon.richards@cdhb.health.nz
Contact person for public queries
Name 79535 0
Prof Frank Frizelle
Address 79535 0
Department of Surgery
University of Otago Christchurch
2 Riccarton Avenue
Christchurch 8140
Country 79535 0
New Zealand
Phone 79535 0
+6433648174
Fax 79535 0
Email 79535 0
frank.frizelle@cdhb.health.nz
Contact person for scientific queries
Name 79536 0
Dr Simon Richards
Address 79536 0
Department of Surgery
Christchurch Public Hospital
2 Riccarton Avenue
Christchurch 8140
Country 79536 0
New Zealand
Phone 79536 0
+6433640014
Fax 79536 0
Email 79536 0
simon.richards@cdhb.health.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No provision for this in consent form as study protocol was written prior to IPD availaibility being encouraged.


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.