Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12609000786291
Ethics application status
Approved
Date submitted
2/09/2009
Date registered
9/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health-related quality of life and illness perception in colorectal surgery
Scientific title
Health-related quality of life and illness perception in colorectal surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal disease 243618 0
Condition category
Condition code
Surgery 239915 239915 0 0
Other surgery
Oral and Gastrointestinal 239963 239963 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is not an interventional trial. This is a validation study of a novel quality of life too. Participant will complete quality of life tools before surgery and day 2, 7 and 14 post-operative. This study will run over a 2 year period.
Intervention code [1] 241206 0
Not applicable
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 240697 0
Construct validity and responsiveness of the ASIS (abdominal surgery impact scale) in patients undergoing elective major colorectal surgery. The ASIS will be correlated to 1) SF-36 Acute (one week recall version of the short form 36 generic quality of life instrument) and 2) symptom scores (self-rated pain, fatigue etc on 0-10 scales). Total scores will be compared, as well as subscales (overall score, physical limitations, functional impairment, pain, visceral function, sleep and psychological function).
Timepoint [1] 240697 0
Pre-operative, Day 2, 7 and 14 post operative.
Secondary outcome [1] 257345 0
Preoperative stress and illness perceptions. The ASIS will be correlated to 1) SF-36 Acute (one week recall version of the short form 36 generic quality of life instrument) and 2) symptom scores (self-rated pain, fatigue etc on 0-10 scales). Total scores will be compared, as well as subscales (overall score, physical limitations, functional impairment, pain, visceral function, sleep and psychological function).
Timepoint [1] 257345 0
Pre-operative

Eligibility
Key inclusion criteria
Patients undergoing elective colorectal surgery at Waitemata District Health Board.
Fluent English speakers and writers.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under the age of 18 years, have
a diagnosed learning disability, or are undergoing a palliative procedure are excluded.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment outside Australia
Country [1] 1970 0
New Zealand
State/province [1] 1970 0
Auckland

Funding & Sponsors
Funding source category [1] 237564 0
Hospital
Name [1] 237564 0
Waitemata District Health Board
Country [1] 237564 0
New Zealand
Funding source category [2] 237567 0
University
Name [2] 237567 0
University of Auckland
Country [2] 237567 0
New Zealand
Primary sponsor type
Individual
Name
Mr Mattias Soop
Address
Dept of Surgery
North Shore Hospital
Private Bag 93 503
Takapuna
Auckland 0740
Country
New Zealand
Secondary sponsor category [1] 237042 0
University
Name [1] 237042 0
University of Auckland
Address [1] 237042 0
Faculty of Medical and Health Sciences
Private Bag 92 019
Auckland 1023
Country [1] 237042 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243695 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 243695 0
3rd Floor, BNZ Building
354 Victoria St
PO Box 1031
Hamilton 3204
Ethics committee country [1] 243695 0
New Zealand
Date submitted for ethics approval [1] 243695 0
18/06/2009
Approval date [1] 243695 0
17/07/2009
Ethics approval number [1] 243695 0
NTY/09/42/EXP

Summary
Brief summary
This study aims to validate the ASIS (Abdominal Surgery Impact Scale) instrument in patients undergoing surgery for colorectal disease. We would like to prove that the ASIS has acceptable validity and responsiveness in colorectal surgical patients. The recruitment goal is 500 patients and the study will be offered to all elective patients having colorectal surgery at Waitemata District Health Board. Patients will be given quality of life questionnaires to complete pre-operatively and then postoperatively on days 2, 7 and 14.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30107 0
Address 30107 0
Country 30107 0
Phone 30107 0
Fax 30107 0
Email 30107 0
Contact person for public queries
Name 13354 0
Lauren Porten
Address 13354 0
Dept of Surgery
North Shore Hospital
Private Bag 93 503
Takapuna
Auckland 0740
Country 13354 0
New Zealand
Phone 13354 0
+64 9 486 8920 extn 7125
Fax 13354 0
+64 9 488 4664
Email 13354 0
[email protected]
Contact person for scientific queries
Name 4282 0
Mr Mattias Soop
Address 4282 0
Dept of Surgery
North Shore Hospital
Private Bag 93 503
Takapuna
Auckland 0740
Country 4282 0
New Zealand
Phone 4282 0
+64 9 486 8920 extn 2459
Fax 4282 0
+64 9 488 4664
Email 4282 0
[email protected]

No information has been provided regarding IPD availability


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.