Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000343707
Ethics application status
Approved
Date submitted
27/10/2021
Date registered
24/02/2022
Date last updated
26/08/2022
Date data sharing statement initially provided
24/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Performance of the TWIST score in the diagnosis of testicular torsion in an Australian Emergency Department
Scientific title
Performance of the TWIST score in the diagnosis of testicular torsion in an Australian Emergency Department
Secondary ID [1] 305672 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Testicular Torsion 324139 0
Acute scrotal pain 324140 0
Condition category
Condition code
Surgery 321613 321613 0 0
Other surgery
Renal and Urogenital 322155 322155 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
This study will look at the demographics, clinical history, physical examination findings and investigation findings of patients presenting with acute scrotal pain and swelling and determine if the TWIST score can be used to safely diagnose or rule out testicular torsion in an Australian paediatric population where ultrasound is not routinely used. We will also use the data to look at other clinical calculators such as the Boettcher Alert Score and Testicular Torsion score.

Each participant will have a clinical history and physical examination (roughly 10 mins each) performed by the emergency department doctor and/or surgical doctor. This will be part of standard care and assessment.
Participants will have observations done as per normal routine care (hourly unless indicated more frequently). They will have physical examination performed as determined by the treating medical team with no change from routine care.

The TWIST score is made up of testicular swelling, hard testis, absent cremasteric reflex, nausea or vomiting and high riding testis and these aspects will be assessed for and documented.

Not all participants will have investigations performed but they may include ultrasound, urine dipstick or STI screen. Results of these investigations will be documented and accessed electronically.
Intervention code [1] 322465 0
Diagnosis / Prognosis
Intervention code [2] 322466 0
Early Detection / Screening
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329377 0
Performance accuracy (sensitivity, specificity, negative predictive value, positive predictive value) of the TWIST score in identifying and diagnosing testicular torsion compared with current practice of clinical acumen alone. Final diagnosis will be base on surgical diagnosis or diagnosis at discharge if they did not go to theatre, (provided they did not represent with subsequent more accurate diagnosis ie missed torsion)
Timepoint [1] 329377 0
At clinical assessment/diagnosis
Secondary outcome [1] 404298 0
Performance accuracy (sensitivity, specificity, negative predictive value, positive predictive value) of Boettcher alert score in diagnosing testicular torsion and compared with clinical acumen. The Boettcher alert score consists of duration of pain < 24 hours, nausea or vomiting, high riding testicle and abnormal cremaster reflex
Timepoint [1] 404298 0
At time of assessment/diagnosis
Secondary outcome [2] 404299 0
Number of representations to hospitals
Timepoint [2] 404299 0
Review of electronic medical records at 28 days
Secondary outcome [3] 404300 0
Rate of missed testicular torsions
Timepoint [3] 404300 0
Review of electronic medical records at 28 days
Secondary outcome [4] 404301 0
Number of ultrasounds performed during study period and diagnosis at ultrasound
Timepoint [4] 404301 0
The medical records of all enrolled participants will be reviewed by research team members for clinical outcome data, including final diagnosis (either clinical if discharged from ED or as per the operation report if taken to theatre), urinalysis, ultrasound, surgical report (if surgery performed), need for interventions (scrotal exploration +/- orchidectomy +/- orchidopexy +/- other), representation to hospital and development of complications (missed torsion, surgical wound infection, return to theatre etc).
These notes will be followed up between 14-28 days. Given the Women’s and Children’s Hospital is the only Hospital with Paediatric Surgical services to deal with testicular torsion then all patients will be re-referred back to WCH if there are any complications or missed torsions. Furthermore, with the Electronic Medical Records it is possible to view presentations and documents from other sites and as such we will be able to capture all relevant follow up data.
Secondary outcome [5] 404302 0
Complication rate
Timepoint [5] 404302 0
The medical records of all enrolled participants will be reviewed by research team members for clinical outcome data, including final diagnosis (either clinical if discharged from ED or as per the operation report if taken to theatre), urinalysis, ultrasound, surgical report (if surgery performed), need for interventions (scrotal exploration +/- orchidectomy +/- orchidopexy +/- other), representation to hospital and development of complications (missed torsion, surgical wound infection, return to theatre etc).
These notes will be followed up between 14-28 days. Given the Women’s and Children’s Hospital is the only Hospital with Paediatric Surgical services to deal with testicular torsion then all patients will be re-referred back to WCH if there are any complications or missed torsions. Furthermore, with the Electronic Medical Records it is possible to view presentations and documents from other sites and as such we will be able to capture all relevant follow up data.
Secondary outcome [6] 404303 0
Tanner stage (pre-pubertal, pubertal, post-pubertal/adult) correlation with TWIST score and final diagnosis
Timepoint [6] 404303 0
Documented at time of clinical assessment - medical records reviewed between 14-28 days
Secondary outcome [7] 404304 0
Correlation of ‘blue dot sign’ presence or absence with final diagnosis
Timepoint [7] 404304 0
Documented at time of clinical assessment - medical records reviewed between 14-28 days
Secondary outcome [8] 404305 0
Performance accuracy (sensitivity, specificity, negative predictive value, positive predictive value) of artifical intelligence score in diagnosing testicular torsion and compared with clinical acumen. The artificial intelligence score consists of duration of pain < 24 hours, nausea or vomiting, high riding testicle and abdominal pain
Timepoint [8] 404305 0
The medical records of all enrolled participants will be reviewed by research team members for clinical outcome data, including final diagnosis (either clinical if discharged from ED or as per the operation report if taken to theatre), urinalysis, ultrasound, surgical report (if surgery performed), need for interventions (scrotal exploration +/- orchidectomy +/- orchidopexy +/- other), representation to hospital and development of complications (missed torsion, surgical wound infection, return to theatre etc).
These notes will be followed up between 14-28 days. Given the Women’s and Children’s Hospital is the only Hospital with Paediatric Surgical services to deal with testicular torsion then all patients will be re-referred back to WCH if there are any complications or missed torsions. Furthermore, with the Electronic Medical Records it is possible to view presentations and documents from other sites and as such we will be able to capture all relevant follow up data.

Eligibility
Key inclusion criteria
Scrotal and/or testicular pain or scrotal swelling
Duration of pain < 7 days
Minimum age
3 Months
Maximum age
18 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Previous testicular torsion
previous scrotal surgery or testicular disease
Intellectual impairment or behavioural issues that will not allow an accurate assessment of patient and hence collection of data
Age < 3 months or > 18 years
Ultrasound confirmed diagnosis of testicular torsion prior to presentation

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data analysis for primary and secondary outcomes will be performed once all data has been collected with no plan for interim analysis.

Performance statistics will be calculated including specificity, sensitivity, NPV and PPV. We will compare the various calculators to clinical acumen alone. Receiver operator characteristics (ROC) will be calculated for all the possible TWIST score points for patients that did have a final (surgical) diagnosis of testicular torsion.

Inter-observer reliability: Given we will have 2 sets of documentation (1 from the ED physician and 1 from the surgeon) for most patients we will have a convenient sample to be able to perform inter-observer reliability calculations. As such we will use a Kappa statistic to calculate the inter-observer reliability.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/08/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 23030 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 38355 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 310031 0
Hospital
Name [1] 310031 0
Women's and Children's Hospital
Country [1] 310031 0
Australia
Primary sponsor type
Individual
Name
Alexander Wilson
Address
72 King William Rd, North Adelaide SA 5006
(The primary sponsor will be Alexander Wilson - there are minimal costs anticipated and these will be covered by him. The above address is his work address - Women's and Children's Hospital)
Country
Australia
Secondary sponsor category [1] 312107 0
None
Name [1] 312107 0
Address [1] 312107 0
Country [1] 312107 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309733 0
Women's and Children's Hospital Human Research Ethics Committee (HREC)
Ethics committee address [1] 309733 0
Ethics committee country [1] 309733 0
Australia
Date submitted for ethics approval [1] 309733 0
22/11/2021
Approval date [1] 309733 0
24/01/2022
Ethics approval number [1] 309733 0
2021/HRE00402

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

Contacts
Principal investigator
Name 115202 0
Dr Alexander Wilson
Address 115202 0
Women's and Children's Hospital
72 King William Road,
North Adelaide 5006 SA
Country 115202 0
Australia
Phone 115202 0
+61 0411814439
Fax 115202 0
Email 115202 0
[email protected]
Contact person for public queries
Name 115203 0
Alexander Wilson
Address 115203 0
Women's and Children's Hospital
72 King William Road,
North Adelaide 5006 SA
Country 115203 0
Australia
Phone 115203 0
+61 0411814439
Fax 115203 0
Email 115203 0
[email protected]
Contact person for scientific queries
Name 115204 0
Alexander Wilson
Address 115204 0
Women's and Children's Hospital
72 King William Road,
North Adelaide 5006 SA
Country 115204 0
Australia
Phone 115204 0
+61 0411814439
Fax 115204 0
Email 115204 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.