Actively Recruiting

Phase Not Applicable
Age: 1Day - 18Years
MALE
ID07252999

Transection Versus Reduction of Hernia Sac in Open Pediatric Inguinal Hernia Repair A Randomized Controlled Trial Study

Led by Piyanuch Lormuangthong · Updated on 2025-11-28

40

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

P

Piyanuch Lormuangthong

Lead Sponsor

R

Ramathibodi Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial focuses on male children under 18 years old who have an inguinal hernia, a condition where abdominal contents push through a weak spot in the groin area due to a persistent opening in the abdominal lining. The study compares two surgical techniques used in open inguinal hernia repair: hernia sac transection and hernia sac reduction. Researchers aim to understand which technique leads to better outcomes during a 6-month follow-up period. Participants will undergo open inguinal hernia surgery using either hernia sac transection or hernia sac reduction, both performed under anesthesia by a pediatric surgeon. After surgery, patients will follow standard care procedures including diagnosis, treatment, and monitoring. The study includes follow-up visits at week 1, month 3, and month 6 to assess recovery and surgical outcomes. During the study, participants will be monitored for complications such as reactive hydrocele, scrotal hematoma, hernia recurrence, and testicular atrophy at specified follow-up times. Painkiller requirements will also be tracked during the first week after surgery. Follow-up may occur in person at the hospital or via phone. The total participation duration is 6 months, during which safety and recovery will be carefully evaluated.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 1Day - 18Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 for 6 months
  • Patients who agree to participate in the study by signing an informed consent form
Not Eligible

You will not qualify if you...

  • 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
  • Patients who refused to participate in the study or withdrawn

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo open inguinal hernia surgery using either hernia sac transection or hernia sac reduction techniques under anesthesia.

1 visit (in-person)

Post-operative Follow-up

Duration - 6 months

Participants are monitored for recovery and complications such as reactive hydrocele, scrotal hematoma, hernia recurrence, testicular atrophy, and pain management after surgery.

Visits at Week 1, Month 3, and Month 6 post-surgery (in-person or phone follow-up)

Trial Site Locations

Total: 1 location

1

Ramathibodi hospital

Ratchathewi, Bangkok, Thailand, 10400

Actively Recruiting

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Research Team

P

Piyanuch Lormuangthong, Doctor of medicine

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Comparison of Hernia Sac Transection and Full Sac Reduction for the Treatment of Inguinal Hernias: A Systematic Review and Meta-Analysis of Clinical Trials.

Roberto Cirocchi, Georgi I Popivanov, Maria Chiara Cianci...

https://pubmed.ncbi.nlm.nih.gov/39856021

Is the open approach superior to the laparoscopic hernia repair in children? A retrospective comparative study.

Raed N Al-Taher, Ibrahim A Khrais, Suhib Alma'aitah...

https://pubmed.ncbi.nlm.nih.gov/34691442

Current concepts in the management of inguinal hernia and hydrocele in pediatric patients in laparoscopic era.

Ciro Esposito, Maria Escolino, Francesco Turrà...

https://pubmed.ncbi.nlm.nih.gov/27521714