Comparing Laparoscopic and Open Surgery for Repairing Unilateral Inguinal Hernia in Children Aged 0 to 16 Years

What this Trial Is About

Researchers are evaluating the cost-effectiveness and outcomes of two surgical techniques for repairing unilateral inguinal hernias in children aged 0 to 16 years. Inguinal hernia repair is a common operation in children, and the study aims to determine whether the laparoscopic Percutaneous Inguinal Ring Suturing PIRS technique or the traditional open hernia repair is the better treatment approach. The laparoscopic method offers the chance to inspect and possibly repair a hidden hernia on the opposite side during surgery. The study compares two groups one receiving the laparoscopic PIRS technique and the other undergoing the open repair technique. Both surgical procedures will be performed in multiple centers with children randomly assigned to each group. The researchers will monitor the number of operations needed, costs, surgery duration, post-operative pain, hospital stay length, recovery time, cosmetic results, and quality of life. These factors will be assessed for up to two years after the initial surgery. Participants will be followed for two years with evaluations of complications, pain levels, hospital stays, and quality of life questionnaires. The study will also track costs from both healthcare and societal perspectives. The main outcome measured is the rate of re-operations related to the hernia repair. Families can expect regular follow-ups during this period to assess recovery and any additional treatment needs. The study is sponsored by the Academic Medical Center at the University of Amsterdam.

The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair