Inguinal HerniaPediatricsNCT06975826
A Comparison Between Two Laparoscopic Techniques in Management of Inguinal Hernias in Pediatrics
A study testing Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia and Laparscopic inguinal herniotomy in pediatrics in people with Inguinal Hernia and Pediatrics, run by Assiut University.
Trial summary
To compare between the use of the percutaneous internal ring suturing (PIRS) technique and the Laparoscopic intraperitoneal purse-string suture sac closure technique. in pediatrics \& evaluate the safety, efficacy feasibility ,operative time ,postoperative pain ,recurrence rate of both approaches. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Inguinal Hernia, Pediatrics
- What is being tested?
- Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia and Laparscopic inguinal herniotomy in pediatrics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 26 May 2025to 20 Oct 2026
- 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 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 1. Age 1month to 18 years. 2. Denovo Inguinal Hernias. 3. Uncomplicated Inguinal Hernias.
Who cannot join
- 1. Complicated Inguinal Hernia 2. Age more than 18 Years 3. cases inwhich laparoscopic surgery is contraindicated 4. cases with collagen disease. 5. Recurrent Inguinal Hernia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparison Between the Percutaneous Internal Ring Suturing (PIRS) Technique and Laparoscopic Intraperitoneal Purse String Suture Sac Closure Technique in Pediatrics
To compare between the use of the percutaneous internal ring suturing (PIRS) technique and the Laparoscopic intraperitoneal purse-string suture sac closure technique. in pediatrics \& evaluate the safety, efficacy feasibility ,operative time ,postoperative pain ,recurrence rate of both approaches.
Read the detailed description
Inguinal hernia repairs (IHRs) are one of the most common procedures performed by pediatric surgeons around the world. Although the open method remains the most common for pediatric IHR, laparoscopic IHR has increased dramatically between 2009 and 2018. Over a dozen different laparoscopic techniques have been developed .With the rise in popularity of laparoscopic IHR, many researchers have set out to examine the differences in efficacy of open IHR compared with various laparoscopic IHR techniques. However, there are few studies directly comparing different laparoscopic techniques. By determining outcome discrepancies among popular laparoscopic techniques for pediatric IHR, we can help improve surgical techniques, postoperative outcomes, and patient satisfaction.The proposed advantages of the laparoscopic approach include visualization of a contralateral PPV, identification of less common (direct, femoral, pantaloon) hernias ,diminished postoperative pain, more rapid return to normal function, and improved cosmesis. Two laparoscopic techniques that have gained popularity among pediatric surgeons in the past decade, the percutaneous internal ring suturing (PIRS) technique and Laparoscopic intraperitoneal purse string suture sac closure technique.
- Conditions
- Inguinal Hernia, Pediatrics
- Being tested
- Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia, Laparscopic inguinal herniotomy in pediatrics
- Keywords
- Laparscopic inguinal herniotomy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal herniaProcedure or surgery
Laparscopic percutaneous internal ring suturing (PIRS) technique
Laparscopic inguinal herniotomy in pediatricsProcedure or surgery
Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics.
| Study group | Role | What they receive |
|---|---|---|
| Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia | Active comparator | Use of laparoscopy in Management of inguinal hernia in pediatrics without entering peritoneal cavity Receives: Procedure: Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia |
| Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics. | Active comparator | Use of laparoscopy in Management of inguinal hernia in pediatrics through entering peritoneal cavity Receives: Procedure: Laparscopic inguinal herniotomy in pediatrics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time in both approaches
time from start of operation to the end
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start26 May 2025 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour eldein Ali Thabet, Advanced Bionics
- Investigators
- Almoataz Ahmed Eltayeb, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975826
- Sponsor's protocol ID
- Laparscopic herniotomy in ped.
- Acronym
- Pediatrics
- Status last verified
- May 2025
- First submitted
- 26 Jan 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Percutaneous Internal Ring Suturing (PIRS) Technique and Laparoscopic Intraperitoneal Purse String Suture Sac Closure Technique in Pediatrics
- ClinicalTrials.gov ID
- NCT06975826
- Acronym / sponsor ID
- Pediatrics / Laparscopic herniotomy in ped.
- Conditions
- Inguinal Hernia, Pediatrics
- Keywords
- Laparscopic inguinal herniotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 May 2025 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Oct 2026 (estimated)
- First posted
- 16 May 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.
To compare between the use of the percutaneous internal ring suturing (PIRS) technique and the Laparoscopic intraperitoneal purse-string suture sac closure technique. in pediatrics \& evaluate the safety, efficacy feasibility ,operative time ,postoperative pain ,recurrence rate of both approaches.
Detailed description
Inguinal hernia repairs (IHRs) are one of the most common procedures performed by pediatric surgeons around the world. Although the open method remains the most common for pediatric IHR, laparoscopic IHR has increased dramatically between 2009 and 2018. Over a dozen different laparoscopic techniques have been developed .With the rise in popularity of laparoscopic IHR, many researchers have set out to examine the differences in efficacy of open IHR compared with various laparoscopic IHR techniques. However, there are few studies directly comparing different laparoscopic techniques. By determining outcome discrepancies among popular laparoscopic techniques for pediatric IHR, we can help improve surgical techniques, postoperative outcomes, and patient satisfaction.The proposed advantages of the laparoscopic approach include visualization of a contralateral PPV, identification of less common (direct, femoral, pantaloon) hernias ,diminished postoperative pain, more rapid return to normal function, and improved cosmesis. Two laparoscopic techniques that have gained popularity among pediatric surgeons in the past decade, the percutaneous internal ring suturing (PIRS) technique and Laparoscopic intraperitoneal purse string suture sac closure technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia | Active comparator | Procedure: Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal herniaUse of laparoscopy in Management of inguinal hernia in pediatrics without entering peritoneal cavity |
| Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics. | Active comparator | Procedure: Laparscopic inguinal herniotomy in pediatricsUse of laparoscopy in Management of inguinal hernia in pediatrics through entering peritoneal cavity |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 1. Age 1month to 18 years. 2. Denovo Inguinal Hernias. 3. Uncomplicated Inguinal Hernias.
Key exclusion criteria (1 listed)
- 1. Complicated Inguinal Hernia 2. Age more than 18 Years 3. cases inwhich laparoscopic surgery is contraindicated 4. cases with collagen disease. 5. Recurrent Inguinal Hernia.
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 |
|---|---|---|
| Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal herniaLaparscopic percutaneous internal ring suturing (PIRS) technique | Procedure or surgery | Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia |
| Laparscopic inguinal herniotomy in pediatricsLaparoscopic intraperitoneal purse string suture sac closure technique in pediatrics. | Procedure or surgery | Laparoscopic intraperitoneal purse string suture sac closure technique in pediatrics. |
Primary outcome
Operative time in both approaches
Time frame: baseline
time from start of operation to the end
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 16 May 2025.
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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.
Almoataz Ahmed Eltayeb study director
Questions about this trial
What is this clinical trial studying?
A study testing Laparscopic percutaneous internal ring suturing (PIRS) technique in Management of inguinal hernia and Laparscopic inguinal herniotomy in pediatrics in people with Inguinal Hernia and Pediatrics, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Nour eldein Ali Thabet (+201111476411, Nour.16266084@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time in both approaches (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.