Effectiveness of total extraperitoneal hernia correction for clinically occult inguinal hernia: a multicenter randomized controlled trial

Recruiting

• Conditions: iesbreuken; groin hernia; Inguinal hernia

• Registration Number: NL-OMON55469
• Lead Sponsor: Diakonessenhuis Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

Adults (18 years or older)
Unilateral groin pain
No features of an inguinal hernia on physical examination
Inguinal hernia diagnosed on ultrasonography (on the side of the groin pain)

Exclusion Criteria

Previous inguinal hernia on the symptomatic side
Previous surgery of the inguinal region at the symptomatic side
BMI 40 or higher
ASA classification above III

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure of this study will be the reduction in pain<br /><br>intensity, measured in rest and during physical activity by the Numeric Rating<br /><br>Scale (NRS), 3 months after treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are: Pain intensity 1.5,6 and 12 months after<br /><br>treatment, quality of life, health care use, duration to resumption of daily<br /><br>and professional activities, positive predictive value of ultrasonography for<br /><br>detection of a clinically occult groin hernia, comparability outcomes of<br /><br>ultrasonography and MRI for detection of a clinically occult groin hernia,<br /><br>cross-over rate, patient satisfaction and cost-effectiveness.</p><br>