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

Objective

To evaluate the (cost-)effectiveness of endoscopic totally extraperitoneal (TEP) inguinal hernia correction compared to watchful waiting in patients with groin pain and a clinically occult inguinal hernia.


Hypothesis

A watchful waiting approach is non-inferior to application of the endoscopic totally extraperitoneal (TEP) inguinal hernia correction in terms of pain reduction and quality of life 3 months after treatment.


Study design

The study design is a multicenter non-blinded randomized controlled non-inferiority trial.


Study population

The study population will consist of patients with groin pain and a clinically occult inguinal hernia; no features of an inguinal hernia can be detected on physical examination, while ultrasonography shows an inguinal hernia on the symptomatic side.


Intervention

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


Comparison

Outcomes of TEP inguinal hernia repair will be compared to a watchful waiting approach. Treatment will consist of rest, painkillers and optional physiotherapy.


Outcome measures

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 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, patient satisfaction and cost effectiveness.


Sample size

Based on the assumption that both treatments will be similar in terms of pain reduction 3 months after treatment, a sample size that could detect the smallest clinically relevant difference between the two treatment modalities was calculated. Using an equivalence margin of a NRS of 0.75, the total sample size should be at least 160 patients, with 80 patients per arm.


Time schedule

The study duration will be 42 months. The first period up to a maximum of 30 months will consist of inclusion and follow-up, in the period hereafter follow-up, data analysis and reporting of the results will be performed.

A watchful waiting approach is non-inferior to application of the endoscopic totally extraperitoneal (TEP) inguinal hernia correction in terms of pain reduction and quality of life 3 months after treatment

Baseline, 1.5 months after treatment, 3 months after treatment, 6 months after treatment, 12 months after treatment

- Endoscopic totally extraperitoneal (TEP) inguinal hernia correction

- Watchful waiting approach (treatment will consist of rest, painkillers and optional physiotherapy)