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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55469
Enrollment
160
Registered
2017-10-10
Start date
2018-01-30
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liesbreuken groin hernia Inguinal hernia

Interventions

The intervention to be evaluated in this study is the endoscopic total extraperitoneal (TEP) inguinal hernia correction.

Sponsors

Diakonessenhuis Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study will be the reduction in pain intensity, measured in rest and during physical activity by the Numeric Rating Scale (NRS), 3 months after treatment.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)