Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000521921
Ethics application status
Approved
Date submitted
28/03/2020
Date registered
28/04/2020
Date last updated
28/04/2020
Date data sharing statement initially provided
28/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Complications in Men who have Undergone Surgical Reconstruction of the Urethra using Oral Grafts
Scientific title
Evaluating Donor Site Complications after Buccal Mucosal Grafting for Urethroplasty
Secondary ID [1] 300879 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urethroplasty 316810 0
Buccal Mucosal Grafting 316811 0
Complications at Donor Site for Buccal Mucosal Graft 316812 0
Condition category
Condition code
Surgery 315020 315020 0 0
Surgical techniques
Renal and Urogenital 315161 315161 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary aim of this retrospective observational study is to determine the occurrence of post-operative complications at the BMG donor site in patients who have undergone BMG harvesting for urethroplasty at Toowoomba Hospital and St Vincent’s Private Hospital between 1st January 2017 and 31st December 2019.

Secondarily, this study will evaluate the demographic, medical and operative characteristics of patients who have undergone BMG harvesting for urethroplasty at Toowoomba Hospital and St Vincent’s Private Hospital between 1st January 2017 and 31st December 2019.

All data will be collected from the pre-existing hospital records of these patients.
Intervention code [1] 317206 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323321 0
To determine the occurrence of the following post-operative complications at the buccal mucosal graft donor site:
i. Infection
ii. Pain
iii. Altered buccal sensation
iv. Difficulty eating
v. Difficulty smiling
vi. Re-operation/Revision surgery

This is a composite primary outcome of post-operative complications. The occurrence of these complications will be determined retrospectively from medical records of participants.
Timepoint [1] 323321 0
Up until 24 months post surgery
Secondary outcome [1] 381551 0
To ascertain if age (years) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Age will be determined from pre-existing hospital medical records.
Timepoint [1] 381551 0
Age at time of surgery
Secondary outcome [2] 381886 0
To ascertain if date of diagnosis is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Date of diagnosis will be determined from pre-existing hospital medical records.
Timepoint [2] 381886 0
Date of diagnosis
Secondary outcome [3] 381887 0
To ascertain if surgeon is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Surgeon will be determined from pre-existing hospital medical records.
Timepoint [3] 381887 0
Surgeon recorded as performing surgery
Secondary outcome [4] 381888 0
To ascertain if BMI is associated with the occurrence of complications at the donor site for the buccal mucosal graft. BMI will be determined from pre-existing hospital medical records.
Timepoint [4] 381888 0
Up until 24 months post surgery
Secondary outcome [5] 381889 0
To ascertain if smoking status (1 cigarette within past 2 months) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Smoking status will be determined from pre-existing hospital medical records.
Timepoint [5] 381889 0
Up until 24 months post surgery
Secondary outcome [6] 381890 0
To ascertain if alcohol consumption status (how many drinks per week) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Alcohol consumption will be determined from pre-existing hospital medical records.
Timepoint [6] 381890 0
Up until 24 months post surgery
Secondary outcome [7] 381891 0
To ascertain if illicit drug use (current and previous) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Illicit drug use will be determined from pre-existing hospital medical records.
Timepoint [7] 381891 0
Up until 24 months post surgery
Secondary outcome [8] 381892 0
To ascertain if comorbidities (i.e. Cardiovascular, Respiratory, Metabolic, Autoimmune, Cognitive, Oncological) are associated with the occurrence of complications at the donor site for the buccal mucosal graft. Comorbidities will be determined from pre-existing hospital medical records.
Timepoint [8] 381892 0
Up until 24 months post surgery
Secondary outcome [9] 381893 0
To ascertain if date of surgery is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Date of surgery will be determined from pre-existing hospital medical records.
Timepoint [9] 381893 0
Date of surgery
Secondary outcome [10] 381894 0
To ascertain if operating time is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Operating time will be determined from pre-existing hospital medical records.
Timepoint [10] 381894 0
Operating time on date of surgery
Secondary outcome [11] 381895 0
To ascertain if date of admission is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Date of admission will be determined from pre-existing hospital medical records.
Timepoint [11] 381895 0
Date of admission for hospital encounter when surgery was performed.
Secondary outcome [12] 381896 0
To ascertain if date of discharge is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Date of discharge will be determined from pre-existing hospital medical records.
Timepoint [12] 381896 0
Date of discharge for hospital encounter when surgery was performed.
Secondary outcome [13] 381897 0
To ascertain if length of stay is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Length of stay will be determined from pre-existing hospital medical records.
Timepoint [13] 381897 0
Length of stay for hospital encounter when surgery was performed.
Secondary outcome [14] 381898 0
To ascertain if readmission (within 30 days) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Readmission will be determined from pre-existing hospital medical records.
Timepoint [14] 381898 0
Up to and including 30 days post date of surgery.
Secondary outcome [15] 381899 0
To ascertain if urethral stricture location is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Urethral stricture location will be determined from pre-existing hospital medical records.
Timepoint [15] 381899 0
Urethral stricture location documented prior to surgery.
Secondary outcome [16] 381900 0
To ascertain if urethral stricture length (cm) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Urethral stricture length will be determined from pre-existing hospital medical records.
Timepoint [16] 381900 0
Urethral stricture length documented prior to surgery.
Secondary outcome [17] 381901 0
To ascertain if buccal mucosal graft length (cm) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Graft length will be determined from pre-existing hospital medical records.
Timepoint [17] 381901 0
Buccal mucosal graft length documented at the time of surgery (i.e. in the operation record).
Secondary outcome [18] 381902 0
To ascertain if buccal mucosal graft width (cm) is associated with the occurrence of complications at the donor site for the buccal mucosal graft. Graft width will be determined from pre-existing hospital medical records.
Timepoint [18] 381902 0
Buccal mucosal graft width documented at the time of surgery (i.e. in the operation record).

Eligibility
Key inclusion criteria
(i) Males (> 18 years of age)
(ii) Patients who have undergone urethroplasty surgeries at Toowoomba Hospital and St Vincent’s Private Hospital
(iii) Procedures performed between the 1st January 2017 and the 31st December 2019.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Males under the age of 18

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Descriptive analysis will be conducted to illustrate trends and observations within the data. Data will be analysed with assistance from a statistician.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16554 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [2] 16555 0
St Vincent's Hospital - Toowoomba
Recruitment postcode(s) [1] 30115 0
4350 - Toowoomba

Funding & Sponsors
Funding source category [1] 305328 0
Self funded/Unfunded
Name [1] 305328 0
Dr Devang Desai
Country [1] 305328 0
Australia
Primary sponsor type
Individual
Name
Dr Devang Desai
Address
Consultant Urologist
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350
Country
Australia
Secondary sponsor category [1] 305697 0
None
Name [1] 305697 0
None
Address [1] 305697 0
None
Country [1] 305697 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305666 0
Darling Downs Health Human Research Ethics Committee
Ethics committee address [1] 305666 0
Daring Downs Hospital and Health Service
Cossart House
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350
Ethics committee country [1] 305666 0
Australia
Date submitted for ethics approval [1] 305666 0
13/02/2020
Approval date [1] 305666 0
18/03/2020
Ethics approval number [1] 305666 0
LNR/2020/QTDD/60280

Summary
Brief summary
1. Background
Urethral strictures are a common cause of urinary issues for men worldwide. Repair of the urethra with a tissue graft taken from inside the cheek is currently the best treatment for long urethral strictures.

Whilst the use of an oral graft to repair urethral strictures is well studied, there has been less research into mouth problems (e.g. pain, infection) after the graft is taken.

2. Aims
This study aims to determine the rate of post-operative mouth problems in men who had an oral graft taken from inside their cheek and used to repair their urethral stricture.

This study will also investigate if certain patient's features (e.g. age, medical conditions) or operative details (e.g. size of oral graft, length of urethral stricture) are more likely to result in complications after the surgery.

3. Hypothesis
Patients who have an oral graft surgically removed are at risk of developing mouth problems.
Some patient features or operative details may increase the likelihood of complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101150 0
Dr Devang Desai
Address 101150 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350
Country 101150 0
Australia
Phone 101150 0
+61 0408154889
Fax 101150 0
Email 101150 0
ddesai@toowoombaurology.com.au
Contact person for public queries
Name 101151 0
Dr Devang Desai
Address 101151 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350
Country 101151 0
Australia
Phone 101151 0
+61 0408154889
Fax 101151 0
Email 101151 0
ddesai@toowoombaurology.com.au
Contact person for scientific queries
Name 101152 0
Dr Devang Desai
Address 101152 0
Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350
Country 101152 0
Australia
Phone 101152 0
+61 0408154889
Fax 101152 0
Email 101152 0
ddesai@toowoombaurology.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient identification and individual participant data will be held with the principal investigators and will not be disclosed for the purpose of the study. Each hospital site will own its own data and intellectual property. The primary database will be located at the DDHHS instance of the Queensland Health approved online database, RedCap. Only the principal investigators conducting this study will have access to this secure database.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7457Ethical approval    379523-(Uploaded-28-03-2020-14-40-28)-Study-related document.pdf
7458Study protocol    379523-(Uploaded-28-03-2020-14-40-56)-Study-related document.doc



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.