About this trial
The goal of this clinical trial is to learn if hernia sac transection works to treat pediatric inguinal hernia. Researchers will compare hernia sac transection to hernia sac reduction (traditional inguinal hernia repair) to see outcome in 6 months. Visit the clinic at week1, month3, month 6 for follow-up.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male pediatric patients under 18 years old
Patients who underwent open inguinal hernia surgery on the affected side by a pediatric surgeon
Patients who had follow-up after inguinal hernia surgery at Ramathibodi Hospital or phone follow-up (Telemed) for 6 months
Patients who agree to participate in the study by signing an informed consent form
Disqualifiers
Preterm infants
Inguinal hernia patients with strangulated hernia
Patients with non-communicating hydrocele
Patients who had follow-up at another hospital after inguinal hernia surgery
Trial design
Parallel
Treatments tested in this trial
Hernia sac transection
Procedure/SurgeryAfter administering anesthesia, a standard open inguinal hernia surgery typically was performed by the surgeon. Open inguinal hernia surgery using hernia sac transection technique. Other practices for the patient were as per standard care, including examination, diagnosis, treatment and follow-up.
hernia sac reduction
Procedure/SurgeryAfter administering anesthesia, a standard open inguinal hernia surgery typically was performed by the surgeon. Open inguinal hernia surgery using hernia sac reduction technique. Other practices for the patient were as per standard care, including examination, diagnosis, treatment and follow-up.
Treatment groups
Trial outcomes
Primary outcomes
Reactive hydrocele
Number of Participants with diagnosed through a physical examination that includes a transillumination test, where a soft, fluid-filled mass in the scrotum will glow with a soft, transparent light
Scrotal hematoma
Number of Participants with diagnosed through a physical examination showing a hard lump, bruising, abnormal skin color, and subcutaneous hemorrhage, sometimes with shallow rugae in the scrotum
Hernia recurrence
Number of Participants with diagnosed through a physical examination showing intermittent bulge in the groin and can not get above mass
Testicular atrophy
Number of Participants with the testicular volume is reduced by 20% from pre- to post-operation after measuring the width, length and height of the testicles in centimeters, it is considered testicular atrophy.
Secondary outcomes
Course of pain killer requirement
Measures the amount of painkiller medication used for less than or equal to 1 day or more than 1 day.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Piyanuch Lormuangthong
Lead sponsor
Mahidol University
Sponsor institution
Ramathibodi Hospital
Collaborator