Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000625976
Ethics application status
Approved
Date submitted
16/04/2020
Date registered
29/05/2020
Date last updated
29/05/2020
Date data sharing statement initially provided
29/05/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring Oral Health in Men after Oral Tissue is Harvested for Urethral Repair Surgery
Scientific title
Exploring the Impact of Buccal Mucosal Graft Harvesting for Urethroplasty on Oral Quality of Life: A Prospective Study
Secondary ID [1] 301047 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Quality of Life 317097 0
Buccal Mucosal Graft Harvesting 317098 0
Urethroplasty 317477 0
Condition category
Condition code
Surgery 315263 315263 0 0
Other surgery
Renal and Urogenital 315264 315264 0 0
Other renal and urogenital disorders
Oral and Gastrointestinal 315580 315580 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Urethral strictures often cause problems in men. The best way to fix urethral strictures is with mucosa from inside the cheek. The mucosa is then grafted inside the penis. This technique is called "buccal mucosa graft harvesting" and it fairly common.

However, there has been little research into complications at the buccal mucosa graft donor site. We want to find out what problems may occur inside the mouth after this operation. We also want to find out if problems are more common in some men.

This study will observe adult men who undergo buccal mucosal graft harvesting for urethroplasty. The primary aim is to explore oral quality of life in men who undergo BMG harvesting for urethroplasty at Toowoomba Hospital and St Vincent’s Private Hospital from the 1st March 2020 onwards.

Participants will be observed for 12 months post surgery. During this time, participants will complete questionnaires about pain and oral quality of life at specific timepoints. The investigators will also collect relevant demographic, medical, and operative data from the medical records of participants.
Intervention code [1] 317352 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323505 0
Oral Quality of Life by administering the validated Oral Impact of Daily Performance (OIDP) questionnaire.
Timepoint [1] 323505 0
i. Pre-operatively
ii. 3 months post-operatively
iii. 6 months post-operatively
iv. 12 months post-operatively
Primary outcome [2] 323506 0
Pain at the buccal mucosal donor site by administering the Visual Analogue Scale (VAS) for pain activity
Timepoint [2] 323506 0
i. Pre-operatively
ii. Day 1 post-operatively
iii. Day 3 post-operatively
iv. 1 week post-operatively
v. 1 month post-operatively
vi. 3 months post-operatively
vii. 6 months post-operatively
viii. 12 months post-operatively
Secondary outcome [1] 382088 0
Readmission within 30 days
Timepoint [1] 382088 0
Up to and including 30 days post surgery
Secondary outcome [2] 382091 0
Re-operation. This will be determined from participant's medical records.
Timepoint [2] 382091 0
Up until and including 12 months post surgery.
Secondary outcome [3] 382991 0
Infection at the buccal mucosa graft donor site AFTER graft harvesting . This will be determined from participant's medical records.
Timepoint [3] 382991 0
Up until and including 12 months post surgery.
Secondary outcome [4] 382992 0
Altered sensation at the buccal mucosa graft donor site AFTER graft harvesting . This will be determined from participant's completed OIDP questionnaires and medical records.
Timepoint [4] 382992 0
Up until and including 12 months post surgery.
Secondary outcome [5] 382993 0
Difficulty eating AFTER graft harvesting . This will be determined from participant's medical records.
Timepoint [5] 382993 0
Up until and including 12 months post surgery.
Secondary outcome [6] 382994 0
Difficulty smiling AFTER graft harvesting . This will be determined from participant's medical records.
Timepoint [6] 382994 0
Up until and including 12 months post surgery.

Eligibility
Key inclusion criteria
In order to be eligible to participate in this project, candidates must fulfil all of the following criteria:
• Male
• Greater than or equal to 18 years of age
• Have capacity to consent
• Undergoing BMG harvesting for urethroplasty at Toowoomba Hospital and St Vincent’s Private Hospital from 1st March 2020 onwards
• Provide written consent via signature of the Participant Consent Form
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are:
• <18 years of age
• Lack capacity to consent
• Do not provide written consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
It is anticipated that this study will afford a sample size of 40-60 participants. This sample size estimate was generated by considering the number of BMG harvesting procedures performed at both study sites in recent years. Since BMG harvesting for urethroplasty is a specialised genitourinary procedure, it is difficult to recruit a large number of participants for a cohort study. Indeed, only a few small studies have been published on morbidity, complications and/or oral quality of life post BMG harvesting to date.

Data will be analysed with assistance from a statistician. Descriptive statistics will be performed to illustrate trends and observations within the data. Wherever possible, inferential statistics will also be used to determine the statistical significance of differences in outcomes between patient subgroups. Statistical tests will be conducted at a p=.05 level where data permits such analysis. Tests will include, but will not be limited to, mean, median, mode, t test, chi square test, analysis of variance and logistic regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16481 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [2] 16482 0
St Vincent's Hospital - Toowoomba
Recruitment postcode(s) [1] 30032 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 305489 0
Self funded/Unfunded
Name [1] 305489 0
Dr Devang Desai
Country [1] 305489 0
Australia
Funding source category [2] 305818 0
Hospital
Name [2] 305818 0
Toowoomba Hospital
Country [2] 305818 0
Australia
Primary sponsor type
Individual
Name
Dr Devang Desai
Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country
Australia
Secondary sponsor category [1] 305887 0
None
Name [1] 305887 0
Address [1] 305887 0
Country [1] 305887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305802 0
Darling Downs Health Human Research Ethics Committee
Ethics committee address [1] 305802 0
L2 Cossart House
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Ethics committee country [1] 305802 0
Australia
Date submitted for ethics approval [1] 305802 0
Approval date [1] 305802 0
07/04/2020
Ethics approval number [1] 305802 0
HREA/2020/QTDD/62141

Summary
Brief summary
1. Background

Urethral strictures often cause problems in men. The best way to fix urethral strictures is with mucosa from inside the cheek. This mucosa is then grafted inside the penis. We want to find out what problems may occur inside the mouth after this operation. We also want to find out if problems are more common in some men.

To do this, we will collect some of your information, like age and your medical problems. We will also record any problems or pain you had after your operation. By doing this, we will better understand mouth problems that arise after taking the mucosal graft. Then in the future, doctors will be better able to inform men about how common these problems are.

2. Aims
The primary aim is to explore oral Quality of Life in men who will undergo buccal mucosal graft harvesting for urethroplasty at Toowoomba Hospital and St Vincent’s Private Hospital from 1st March 2020 onwards.

Secondarily, this study will evaluate the occurrence of post-operative complications at the buccal mucosal graft donor site.

This study will also investigate if certain demographic, medical, and operative variables are associated with post-operative complications and poorer oral quality of life.

3. Hypothesis
Post-operative complications at the buccal mucosa graft donor site result in a poorer oral quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101646 0
Dr Devang Desai
Address 101646 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country 101646 0
Australia
Phone 101646 0
+61 0408154889
Fax 101646 0
Email 101646 0
[email protected]
Contact person for public queries
Name 101647 0
Dr Devang Desai
Address 101647 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country 101647 0
Australia
Phone 101647 0
+61 0408154889
Fax 101647 0
Email 101647 0
[email protected]
Contact person for scientific queries
Name 101648 0
Dr Devang Desai
Address 101648 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
QLD
4350
Country 101648 0
Australia
Phone 101648 0
+61 0408154889
Fax 101648 0
Email 101648 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.