Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07499024 for Testicular Torsion, Acute Scrotum, Scrotal Pain is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Evaluation of the Diagnostic Performance of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) Score for Assessing the Risk of Testicular Torsion in Adult Patients Presenting to the Emergency Department With Scrotal Pain - A Prospective Observational Study 1,000 Pediatric Observational
Clinical Trial NCT07499024 is an observational study for Testicular Torsion, Acute Scrotum, Scrotal Pain that is recruiting. It started on February 1, 2026 with plans to enroll 1,000 participants. Led by University Hospital, Linkoeping, it is expected to complete by December 31, 2029. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief Summary
This prospective multicenter observational study aims to evaluate the diagnostic accuracy of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) score in adult patients presenting with acute scrotal pain in Swedish Emergency Departments.
The TWIST score is a clinical decision tool originally validated in pediatric populations to stratify patients into low, intermediate, and high risk for testicular tors...
Show MoreDetailed Description
Acute scrotal pain is a common presentation in Emergency Departments, but the diagnosis of testicular torsion (TT) is relatively rare. Prompt identification is crucial because TT requires urgent surgical intervention to preserve testicular viability. Delays in diagnosis, particularly due to unnecessary imaging or non-standardized clinical assessment, may result in testicular loss.
The TWIST (Testicular Workup for Is...
Show MoreOfficial Title
Evaluation of the Diagnostic Performance of the Testicular Workup for Ischemia and Suspected Torsion (TWIST) Score for Assessing the Risk of Testicular Torsion in Adult Patients Presenting to the Emergency Department With Scrotal Pain
Conditions
Testicular TorsionAcute ScrotumScrotal PainOther Study IDs
- UHLinkoeping
- 2025-07400-01 (Other Identifier) (Swedish Ethical Review Authority approval number)
NCT ID Number
Start Date (Actual)
2026-02-01
Last Update Posted
2026-03-27
Completion Date (Estimated)
2029-12-31
Enrollment (Estimated)
1,000
Study Type
Observational
Status
Recruiting
Keywords
Testicular Torsion
Acute Scrotum
Testicular Workup for Ischemia and Suspected Torsion (TWIST)
Acute Scrotum
Testicular Workup for Ischemia and Suspected Torsion (TWIST)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Adult ED Patients with Acute Scrotal Pain All participants are assessed according to routine clinical care in the Emergency Department.
The TWIST score is calculated from standard clinical findings but does not influence management; decisions regarding imaging or surgery follow usual clinical practice.
Data on symptoms, TWIST score components, and outcomes (including surgical confirmation of testicular torsion) are collected prospectively. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Diagnostic Accuracy of the TWIST Score (Low-Risk Group) | Number and proportion of adult patients with a low-risk TWIST score (0-2) who are confirmed not to have testicular torsion based on surgical exploration or follow-up within 30 days. This measures the sensitivity of the TWIST score to safely rule out torsion. | Up to 30 days from ED visit |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Time to exploration | Time in hours from patient arrival in the Emergency Department to surgical intervention for suspected testicular torsion. | 30 days from ED visit |
Testicular torsion | Number of testicular torsions found up to 30 days from ED visit | 30 days from inclusion |
Pain at study inclusion | Pain at inclusion to the study measured by NRS | Up to one hour from inclusion in the study. |
Use of Ultrasound | If ultrasound was used during the Emergency Department visit | Up to 48 hours from inclusion or ED discharge, whichever comes first |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Male
- Male patients aged 18-40 years
Presenting to the Emergency Department with acute scrotal pain or scrotal symptoms
Suspicion of testicular torsion before clinical assessment
- Scrotal pain or symptoms caused by trauma
Symptom duration > 1 week
History of testicular surgery
Inability to provide informed consent (e.g., language barrier or cognitive limitation)
Study Responsible Party
Daniel Wilhelms, Principal Investigator, MD,PHD, University Hospital, Linkoeping
Study Central Contact
Contact: Jens Wretborn, MD, PhD, +461030000, [email protected]
1 Study Locations in 1 Countries
Östergötland County
Linköping University Hospital, ED, Linköping, Östergötland County, 58185, Sweden
Jens Ragnar Wretborn, MD, PhD, Contact, +46, [email protected]
Recruiting