ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Urethroplasty

Buccal Mucosal Grafting

Complications at Donor Site for Buccal Mucosal Graft

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Up until 24 months post surgery

Secondary outcome [1]

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]

Age at time of surgery

Secondary outcome [2]

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]

Date of diagnosis

Secondary outcome [3]

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]

Surgeon recorded as performing surgery

Secondary outcome [4]

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]

Up until 24 months post surgery

Secondary outcome [5]

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]

Up until 24 months post surgery

Secondary outcome [6]

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]

Up until 24 months post surgery

Secondary outcome [7]

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]

Up until 24 months post surgery

Secondary outcome [8]

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]

Up until 24 months post surgery

Secondary outcome [9]

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]

Date of surgery

Secondary outcome [10]

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]

Operating time on date of surgery

Secondary outcome [11]

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]

Date of admission for hospital encounter when surgery was performed.

Secondary outcome [12]

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]

Date of discharge for hospital encounter when surgery was performed.

Secondary outcome [13]

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]

Length of stay for hospital encounter when surgery was performed.

Secondary outcome [14]

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]

Up to and including 30 days post date of surgery.

Secondary outcome [15]

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]

Urethral stricture location documented prior to surgery.

Secondary outcome [16]

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]

Urethral stricture length documented prior to surgery.

Secondary outcome [17]

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]

Buccal mucosal graft length documented at the time of surgery (i.e. in the operation record).

Secondary outcome [18]

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]

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?

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]

Toowoomba Hospital - Toowoomba

Recruitment hospital [2]

St Vincent's Hospital - Toowoomba

Recruitment postcode(s) [1]

4350 - Toowoomba

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr Devang Desai

Address [1]

Consultant Urologist
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Darling Downs Health Human Research Ethics Committee

Ethics committee address [1]

Daring Downs Hospital and Health Service
Cossart House
Toowoomba Hospital 
154 West Street
Toowoomba
Queensland
4350

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/02/2020

Approval date [1]

18/03/2020

Ethics approval number [1]

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

Dr Devang Desai

Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350

Country

Australia

Phone

+61 0408154889

Fax

[email protected]

Contact person for public queries

Name

Devang Desai

Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350

Country

Australia

Phone

+61 0408154889

Fax

[email protected]

Contact person for scientific queries

Name

Devang Desai

Address

Department of Urology
Toowoomba Hospital
154 West Street
Toowoomba
Queensland
4350

Country

Australia

Phone

+61 0408154889

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
7457	Ethical approval					379523-(Uploaded-28-03-2020-14-40-28)-Study-related document.pdf
7458	Study 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.

Trial Review

Documents added manually

Documents added automatically