Lichtenstein versus Onstep for inguinal hernia repair: protocol for a double-blinded randomised trial

Area of Science:

• Surgical Innovation
• Clinical Trials
• Hernia Repair

Background:

• Inguinal hernia repair is common, with over 10,000 annual procedures in Denmark.
• Debate persists regarding optimal mesh placement and fixation due to long-term complications like chronic pain and sexual dysfunction.
• The Onstep approach shows promise for reducing chronic pain and recurrences in preliminary studies.

Purpose of the Study:

• To evaluate chronic pain and sexual dysfunction after inguinal hernia repair.
• To compare the Lichtenstein repair with the newer Onstep approach.
• To provide evidence for clinical guidelines and future research in hernia repair.

Main Methods:

• A two-arm, blinded, multicenter randomized clinical trial.
• Recruitment of 282 patients (141 per group) across five Danish centers.
• One-year follow-up including clinical examination, phone interviews, and questionnaires.

Main Results:

• This section is not yet available as the study is ongoing with recruitment.
• The study is designed to collect data on chronic pain and sexual dysfunction.
• Results will be analyzed after the one-year follow-up period for all participants.

Conclusions:

• This is the first randomized clinical trial comparing the Lichtenstein repair and Onstep technique.
• Results will inform clinical guidelines and future research directions for inguinal hernia repair.
• The study aims to clarify the long-term outcomes, specifically regarding pain and sexual function.