Inguinal Hernia RepairNCT07252999
Comparison of Outcomes of Hernia Sac Transection and Sac Reduction in Open Pediatric Inguinal Hernia Repair in Ramathibodi Hospital
A study testing Hernia sac transection and hernia sac reduction in people with Inguinal Hernia Repair, run by Piyanuch Lormuangthong at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years, men only
- Conditions the study is for
- Inguinal Hernia Repair
- What is being tested?
- Hernia sac transection and hernia sac reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 31 Oct 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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- Patients who refused to participate in the study or withdrawn
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi hospital
Ratchathewi, Bangkok, 10400
Piyanuch Lormuangthong, +873063838, piyanuch.lor@student.mahidol.ac.th
About this study
Official title: Transection Versus Reduction of Hernia Sac in Open Pediatric Inguinal Hernia Repair: A Randomized Controlled Trial Study
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.
Read the detailed description
An inguinal hernia is a common condition in children where abdominal contents push through a weak spot in the abdominal wall into the groin area. Normally, when the testicles move from the abdomen into the scrotum, the peritoneal lining is pulled downward with them through the inguinal canal. The testicles are fully descended into the scrotum at about eighth months of gestation. Afterward, the opening created by this pouch closes and dissolves. The persistence of this inguinal canal, which should have closed spontaneously, is a common cause of hernias in children, with an incidence of 3.5-5% and it increases up to 44-55% in premature infants. Inguinal hernias often require surgical repair due to the risk of complications like bowel obstruction, which occurs in a significant percentage of cases with an incidence of 3-16%. Open surgery remains the most common method for inguinal hernias. A study by Chukwubuike KE et al. found that pediatric inguinal hernia repair had a postoperative complication rate of 9.9%. The most common complications were scrotal edema, scrotal hematoma, wound infection, hernia recurrence, testicular atrophy และsensory disturbance in the groin region.
Laparoscopic hernia surgery has become more widely used since the first operation in 1993. In this procedure, the hernia sac is cut open and the patent processus vaginalis is used to tighten the internal inguinal ring to prevent future hernias. The purse-string technique is used to close the opening of the internal ring without removing the hernia sac. Laparoscopic surgery offers faster recovery and less risk of spermatic cord injury, with similar operative times and shorter hospital stays compared to open surgery. However, it requires a higher initial cost and the expertise of a surgeon experienced in the procedure.
In a study by Kelly Dreuning, Laparoscopic versus open pediatric inguinal hernia repair: state of the art comparison and future perspectives from a meta-analysis, laparoscopic and open hernia repairs were performed in 375 and 358 patients, respectively. There was no difference in recurrence between the two groups.
Open hernia repair is still used for pediatric patients at Ramathibodi Hospital in order to remove the hernia sac from the spermatic cord. It is a complicated procedure, especially when dealing with big hernias. In a study by Roberto Cirocchi et al., Comparison of hernia sac transection and full sac reduction for the treatment of inguinal hernia: A systematic review and meta-analysis of clinical trials, 1,824 patients were included in the systematic review and meta-analysis of clinical trials which comprised 12 randomized controlled trials (RCTs) and 3 controlled clinical trials (CCTs). Nine hundred and thirty-five of these 1,824 patients had hernia sac transection, and nine hundred and sixty-six had hernia sac reduction. The study found that the two techniques were similar in terms of primary and secondary outcomes, even though hernia sac reduction might lead to a lower, albeit not statistically significant, recurrence rate.
The study by Mohamed Ali Chaouch et al., A systematic review and meta-analysis of hernia sac management in laparoscopic groin hernia mesh repair: reduction or transection, is a systematic review and meta-analysis (PRISMA) study which included 6 studies with a total of 2,941 patients: 821 in the transection group and 2,120 in the reduction group. It was found that the transection group had a significantly lower rate of postoperative seroma than the reduction group (OR = 1.71; 95% CI [1.22, 2.39], p = 0.002). However, there was no significant difference between the two groups in operative time (MD = -4.39; 95%CI [-13.62, 4.84], p = 0.35) and recurrence rate (OR = 2.70; 95%CI [0.50,14.50], p = 0.25)
The aforementioned information indicates that research has been done on the rates of complications following hernia surgery involving the excision of the hernia sac by reduction and transection. However, as of now, there are no conclusive findings about laparoscopic surgery. Thus, this study aimed to assess the rates of complications in pediatric patients who underwent open hernia surgery using reduction and transection techniques.
- Conditions
- Inguinal Hernia Repair
- Being tested
- Hernia sac transection, hernia sac reduction
- Keywords
- hernia sac transection, hernia sac reduction, open inguinal hernia repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia sac transectionProcedure or 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 reductionProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Hernia sac transection | Experimental | Patients who underwent open inguinal hernia surgery using hernia sac transection technique. Receives: Procedure: Hernia sac transection |
| Hernia sac reduction | Active comparator | Patients who underwent open inguinal hernia surgery using hernia sac reduction technique. Receives: Procedure: hernia sac reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: post-operative follow-up at week1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start31 Oct 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Inguinal Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Piyanuch Lormuangthong
- Sponsor type
- University, hospital or other
- Collaborators
- Ramathibodi Hospital
- Responsible party
- Sponsor-investigator, Piyanuch Lormuangthong, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252999
- Sponsor's protocol ID
- MURA2025/684
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39856021Al-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.
PubMed 34691442Esposito 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.
PubMed 27521714Kevin E, Chukwubuike K. Complications of inguinal hernia repair in children: A tertiary hospital experience. Journal of Kathmandu Medical College. 2021;9.
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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transection Versus Reduction of Hernia Sac in Open Pediatric Inguinal Hernia Repair: A Randomized Controlled Trial Study
- ClinicalTrials.gov ID
- NCT07252999
- Acronym / sponsor ID
- MURA2025/684
- Conditions
- Inguinal Hernia Repair
- Keywords
- hernia sac transection, hernia sac reduction, open inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Piyanuch LormuangthongUniversity, hospital or other
- Collaborators
- Ramathibodi Hospital
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An inguinal hernia is a common condition in children where abdominal contents push through a weak spot in the abdominal wall into the groin area. Normally, when the testicles move from the abdomen into the scrotum, the peritoneal lining is pulled downward with them through the inguinal canal. The testicles are fully descended into the scrotum at about eighth months of gestation. Afterward, the opening created by this pouch closes and dissolves. The persistence of this inguinal canal, which should have closed spontaneously, is a common cause of hernias in children, with an incidence of 3.5-5% and it increases up to 44-55% in premature infants. Inguinal hernias often require surgical repair due to the risk of complications like bowel obstruction, which occurs in a significant percentage of cases with an incidence of 3-16%. Open surgery remains the most common method for inguinal hernias. A study by Chukwubuike KE et al. found that pediatric inguinal hernia repair had a postoperative complication rate of 9.9%. The most common complications were scrotal edema, scrotal hematoma, wound infection, hernia recurrence, testicular atrophy และsensory disturbance in the groin region.
Laparoscopic hernia surgery has become more widely used since the first operation in 1993. In this procedure, the hernia sac is cut open and the patent processus vaginalis is used to tighten the internal inguinal ring to prevent future hernias. The purse-string technique is used to close the opening of the internal ring without removing the hernia sac. Laparoscopic surgery offers faster recovery and less risk of spermatic cord injury, with similar operative times and shorter hospital stays compared to open surgery. However, it requires a higher initial cost and the expertise of a surgeon experienced in the procedure.
In a study by Kelly Dreuning, Laparoscopic versus open pediatric inguinal hernia repair: state of the art comparison and future perspectives from a meta-analysis, laparoscopic and open hernia repairs were performed in 375 and 358 patients, respectively. There was no difference in recurrence between the two groups.
Open hernia repair is still used for pediatric patients at Ramathibodi Hospital in order to remove the hernia sac from the spermatic cord. It is a complicated procedure, especially when dealing with big hernias. In a study by Roberto Cirocchi et al., Comparison of hernia sac transection and full sac reduction for the treatment of inguinal hernia: A systematic review and meta-analysis of clinical trials, 1,824 patients were included in the systematic review and meta-analysis of clinical trials which comprised 12 randomized controlled trials (RCTs) and 3 controlled clinical trials (CCTs). Nine hundred and thirty-five of these 1,824 patients had hernia sac transection, and nine hundred and sixty-six had hernia sac reduction. The study found that the two techniques were similar in terms of primary and secondary outcomes, even though hernia sac reduction might lead to a lower, albeit not statistically significant, recurrence rate.
The study by Mohamed Ali Chaouch et al., A systematic review and meta-analysis of hernia sac management in laparoscopic groin hernia mesh repair: reduction or transection, is a systematic review and meta-analysis (PRISMA) study which included 6 studies with a total of 2,941 patients: 821 in the transection group and 2,120 in the reduction group. It was found that the transection group had a significantly lower rate of postoperative seroma than the reduction group (OR = 1.71; 95% CI [1.22, 2.39], p = 0.002). However, there was no significant difference between the two groups in operative time (MD = -4.39; 95%CI [-13.62, 4.84], p = 0.35) and recurrence rate (OR = 2.70; 95%CI [0.50,14.50], p = 0.25)
The aforementioned information indicates that research has been done on the rates of complications following hernia surgery involving the excision of the hernia sac by reduction and transection. However, as of now, there are no conclusive findings about laparoscopic surgery. Thus, this study aimed to assess the rates of complications in pediatric patients who underwent open hernia surgery using reduction and transection techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hernia sac transection | Experimental | Procedure: Hernia sac transectionPatients who underwent open inguinal hernia surgery using hernia sac transection technique. |
| Hernia sac reduction | Active comparator | Procedure: hernia sac reductionPatients who underwent open inguinal hernia surgery using hernia sac reduction technique. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hernia sac transectionAfter 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. | Procedure or surgery | Hernia sac transection |
| hernia sac reductionAfter 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. | Procedure or surgery | Hernia sac reduction |
Primary outcome
Reactive hydrocele
Time frame: post-operative follow-up at week1, month3, month6
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
Time frame: post-operative follow-up at week1, month3, month6
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
Time frame: post-operative follow-up at month3, month6
Number of Participants with diagnosed through a physical examination showing intermittent bulge in the groin and can not get above mass
Testicular atrophy
Time frame: post-operative follow-up at month3, month6
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.
1 secondary outcome
Course of pain killer requirement
Time frame: post-operative follow-up at week1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Results publication: PubMed 39856021Cirocchi 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.
- Results publication: PubMed 34691442Al-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.
- Results publication: PubMed 27521714Esposito 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.
- Results publicationKevin E, Chukwubuike K. Complications of inguinal hernia repair in children: A tertiary hospital experience. Journal of Kathmandu Medical College. 2021;9.
- Results publicationAihole JS. The demographic profile and the management of infantile inguinal hernia: a 3-year's review. African Journal of Urology. 2020;26(1):28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hernia sac transection and hernia sac reduction in people with Inguinal Hernia Repair, run by Piyanuch Lormuangthong at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Piyanuch Lormuangthong, Doctor of medicine (+66873063838, piyanuch.lor@student.mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive hydrocele (time frame: post-operative follow-up at week1, month3, month6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07252999, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.