Comparison of Outcomes of Hernia Sac Transection and Sac Reduction in Open Pediatric Inguinal Hernia Repair in Ramathibodi Hospital

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age1-18
SponsorPiyanuch Lormuangthong

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hernia sac transection

    Procedure/Surgery

    After 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/Surgery

    After 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

40 Participants
are divided into 2 treatment groups
Group A: Hernia sac transectionExperimental treatment 1 intervention
Group B: Hernia sac reductionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
post-operative follow-up at week1, month3, month6
2

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

Time frame
post-operative follow-up at week1, month3, month6
3

Hernia recurrence

Number of Participants with diagnosed through a physical examination showing intermittent bulge in the groin and can not get above mass

Time frame
post-operative follow-up at month3, month6
4

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.

Time frame
post-operative follow-up at month3, month6

Secondary outcomes

1

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.

Time frame
post-operative follow-up at week1

Other outcomes

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