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

NCT07252999 | Recruiting DMC

• 1 other identifier: MURA2025/684
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inguinal Hernia Repair

Keywords

hernia sac transection; hernia sac reduction; open inguinal hernia repair

Outcome Measures

Primary Outcomes (4)

• 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

  post-operative follow-up at week1, month3, month6

• 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

  post-operative follow-up at week1, month3, month6

• Hernia recurrence

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

  post-operative follow-up at month3, month6

• 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.

  post-operative follow-up at month3, month6

Secondary Outcomes (1)

• Course of pain killer requirement

  post-operative follow-up at week1

Study Arms (2)

Hernia sac transection

EXPERIMENTAL

Patients who underwent open inguinal hernia surgery using hernia sac transection technique.

Procedure: Hernia sac transection

Hernia sac reduction

ACTIVE COMPARATOR

Patients who underwent open inguinal hernia surgery using hernia sac reduction technique.

Procedure: hernia sac reduction

Interventions

Hernia sac transection PROCEDURE

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 transection

hernia sac reduction PROCEDURE

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.

Hernia sac reduction

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piyanuch Lormuangthong: lead
• Ramathibodi Hospital: collaborator

Study Sites (1)

Ramathibodi hospital

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Related Publications (5)

• Cirocchi R, Popivanov GI, Cianci MC, Morabito A, Matteucci M, Lauricella S, Cassini D, Boselli C, Szergyuk I, Tebala GD, Rizzuto A, Bruzzone P. Comparison of Hernia Sac Transection and Full Sac Reduction for the Treatment of Inguinal Hernias: A Systematic Review and Meta-Analysis of Clinical Trials. World J Surg. 2025 Mar;49(3):590-604. doi: 10.1002/wjs.12474. Epub 2025 Jan 24.

  PMID: 39856021 RESULT

• Al-Taher RN, Khrais IA, Alma'aitah S, Al Saiad AA, Al-Abboodi AA, Saleh OM, Dwekat N, Almaaitah HW, Bello ZM, Rashdan MZ. Is the open approach superior to the laparoscopic hernia repair in children? A retrospective comparative study. Ann Med Surg (Lond). 2021 Sep 22;71:102889. doi: 10.1016/j.amsu.2021.102889. eCollection 2021 Nov.

  PMID: 34691442 RESULT

• Esposito C, Escolino M, Turra F, Roberti A, Cerulo M, Farina A, Caiazzo S, Cortese G, Servillo G, Settimi A. Current concepts in the management of inguinal hernia and hydrocele in pediatric patients in laparoscopic era. Semin Pediatr Surg. 2016 Aug;25(4):232-40. doi: 10.1053/j.sempedsurg.2016.05.006. Epub 2016 May 11.

  PMID: 27521714 RESULT

• Kevin E, Chukwubuike K. Complications of inguinal hernia repair in children: A tertiary hospital experience. Journal of Kathmandu Medical College. 2021;9.

  RESULT

• Aihole JS. The demographic profile and the management of infantile inguinal hernia: a 3-year's review. African Journal of Urology. 2020;26(1):28.

  RESULT

Central Study Contacts

Piyanuch Lormuangthong, Doctor of medicine

CONTACT

+66873063838; piyanuch.lor@student.mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 28, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)