Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324565
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-15
Brief Title:
Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
The Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion in Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adnexal torsion is the fifth most common gynecologic emergency Thirty percent of all cases of adnexal torsion occur in females younger than 20 years Approximately 5 of 100000 females aged 1-20 years are affected with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent non-radiating and associated with nausea and vomiting in 62 and 67 of cases respectively Moreover abdominal tenderness is a clinical sign which is reported in up to 88 of patients with adnexal torsion None of the following tests are useful in the diagnosis of adnexal torsion leukocytosis pyuria C-reactive protein and erythrocyte sedimentation rate Actually transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92 and specificity of 96 in detecting adnexal torsion A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance which may require a sedation in selected cases Consequently there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date Therefore patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None