Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000707864
Ethics application status
Approved
Date submitted
28/06/2012
Date registered
3/07/2012
Date last updated
14/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changes in men’s health after bariatric surgery
Scientific title
A questionnaire-based study of the self-reported health and quality of life of severely obese men seeking bariatric surgery, before and 1 year after primary bariatric surgery.
Secondary ID [1] 280751 0
Nil
Universal Trial Number (UTN)
U1111-1132-2172
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 286803 0
Sexual function 286804 0
Quality of life 286805 0
Bariatric surgery 286806 0
Condition category
Condition code
Diet and Nutrition 287113 287113 0 0
Obesity
Surgery 287114 287114 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a questionnaire-based study of 140 severely obese men from around Australia who will have elected to undergo bariatric surgery for weight loss and will undergo routine pre- and post-surgical clinical care. All data will be collected in a coded and de-identified format.
Before surgery, each participant will complete questionnaires about sexual, occupational and social function and quality of life. Anthropometric, demographic, medical and medication history information will also be collected from the surgical practice where the participant was recruited.
All questionnaires and data collection will be repeated 12 months after bariatric surgery.
Intervention code [1] 285178 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287436 0
Improvement in sexual function, assessed by change in score on the International index of erectile function (IIEF), with a 3.0-point improvement being clinically relevant.
Timepoint [1] 287436 0
All participants will complete the IIEF at baseline and 1 year post-bariatric surgery.
Primary outcome [2] 287437 0
Improvement in quality of life, assessed by percentage change in total scores and scores on each scale of the SF-36 and work productivity, assessed by percentage change in scores on the Endicott Work Productivity Scale (EWPS).
Timepoint [2] 287437 0
All participants will complete the SF-36 and EWPS at baseline and 1 year post-bariatric surgery.
Secondary outcome [1] 298144 0
The relationship between baseline anthropometry, medical history and medication use and changes in sexual function (assessed using the IIEF), assessed using linear regression and logistic regression, in exploratory analysis.
Timepoint [1] 298144 0
All participants will complete the IIEF at baseline and 1 year post-bariatric surgery. The change in score between timepoints will be explored in the context of baseline medical history, anthropometry and medication use.
Secondary outcome [2] 298145 0
The relationship between baseline anthropometry, medical history and medication use and changes in quality of life(assessed using the SF-36), assessed using linear regression and logistic regression, in exploratory analysis.
Timepoint [2] 298145 0
All participants will complete the SF-36 at baseline and 1 year post-bariatric surgery. The change in score between timepoints will be explored in the context of baseline medical history, anthropometry and medication use.
Secondary outcome [3] 298146 0
The relationship between percentage weight loss and changes in sexual function (assessed using the IIEF).
Timepoint [3] 298146 0
All participants will complete the IIEF at baseline and 1 year post-bariatric surgery and will have bodyweights recorded at baseline and 1 year, allowing percentage weight loss to be calculated.
Secondary outcome [4] 298147 0
The relationship between percentage weight loss and changes in quality of life(assessed using the SF36).
Timepoint [4] 298147 0
All participants will complete the SF-36 at baseline and 1 year post-bariatric surgery and will have bodyweights recorded at baseline and 1 year, allowing percentage weight loss to be calculated.
Secondary outcome [5] 298176 0
The cross-sectional associations between demographic (marital status, employment, ethnicity), anthropometric (weight, BMI, waist circumference)and comorbidity characteristics (medical history, medication use, HADS questionnaire for symptoms of anxiety and depression), and sexual dysfunction (assessed using IIEF) and poor quality of life (assessed via SF-36 and EWPS) in severely obese men. General linear regression and logistic regression analyses will be performed, in an exploratory manner.
Timepoint [5] 298176 0
All measures will be recorded at baseline and 1 year post-surgery, but for this exploratory analysis, only baseline data will be considered.

Eligibility
Key inclusion criteria
Severely obese men presenting for any primary bariatric surgery.
Aged 18 years or over.
Eligible for bariatric surgery according to the criteria of the surgical practice through which they are enrolled.
Able to give written informed consent for participation in the study which includes completing questionnaires at 1 year after surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men taking any medications or undergoing other therapy specifically for erectile dysfunction.
Men who have previously had any form of bariatric surgery.
Men who do not have the capacity to give written informed consent for their involvement in the study.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/06/2011
Actual
3/05/2011
Date of last participant enrolment
Anticipated
30/06/2014
Actual
24/01/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment postcode(s) [1] 5463 0
2153
Recruitment postcode(s) [2] 5464 0
2217
Recruitment postcode(s) [3] 5465 0
3155
Recruitment postcode(s) [4] 5466 0
3123
Recruitment postcode(s) [5] 5467 0
4305
Recruitment postcode(s) [6] 5468 0
4120
Recruitment postcode(s) [7] 5469 0
2290
Recruitment postcode(s) [8] 5470 0
2065
Recruitment postcode(s) [9] 5471 0
4066
Recruitment postcode(s) [10] 5472 0
3121
Recruitment postcode(s) [11] 5473 0
6150
Recruitment postcode(s) [12] 5474 0
4812
Recruitment postcode(s) [13] 5475 0
3016
Recruitment postcode(s) [14] 5476 0
3128
Recruitment postcode(s) [15] 5477 0
2600
Recruitment postcode(s) [16] 12522 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 285541 0
Commercial sector/Industry
Name [1] 285541 0
Allergan
Country [1] 285541 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart & Diabetes Institute
Address
Baker IDI Heart & Diabetes Institute
75 Commercial Road
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 284380 0
None
Name [1] 284380 0
Address [1] 284380 0
Country [1] 284380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287561 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 287561 0
Ethics committee country [1] 287561 0
Australia
Date submitted for ethics approval [1] 287561 0
Approval date [1] 287561 0
02/02/2010
Ethics approval number [1] 287561 0
CF09/3250 - 2009001771
Ethics committee name [2] 294160 0
The Alfred Health Human Ethics Committee
Ethics committee address [2] 294160 0
Ethics committee country [2] 294160 0
Australia
Date submitted for ethics approval [2] 294160 0
Approval date [2] 294160 0
19/06/2013
Ethics approval number [2] 294160 0
210/13

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34375 0
Prof John Dixon
Address 34375 0
Baker IDI Heart & Diabetes Institute
75 Commercial Road
Melbourne VIC 3004
Country 34375 0
Australia
Phone 34375 0
+61 3 8532 1111
Fax 34375 0
Email 34375 0
[email protected]
Contact person for public queries
Name 17622 0
John Dixon
Address 17622 0
Baker IDI Heart & Diabetes Institute
75 Commercial Road
Melbourne VIC 3004
Country 17622 0
Australia
Phone 17622 0
+61 3 8532 1115
Fax 17622 0
+61 3 8532 1100
Email 17622 0
[email protected]
Contact person for scientific queries
Name 8550 0
John Dixon
Address 8550 0
Baker IDI Heart & Diabetes Institute
75 Commercial Road
Melbourne VIC 3004
Country 8550 0
Australia
Phone 8550 0
+61 3 8532 1115
Fax 8550 0
+61 3 8532 1100
Email 8550 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
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