Laparoscopic Percutaneous Extra-peritoneal ClosureNCT07102277
Laparoscopic Percutaneous Extra-peritoneal Closure of the Internal Ring With or Without Peritoneal Cauterization
An observational study of Laparoscopic Percutaneous Extra-peritoneal Closure and Internal Ring, run by Tanta University at 1 site in Egypt.
Trial summary
This research project aims to evaluate pediatric patients who underwent laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Laparoscopic Percutaneous Extra-peritoneal Closure, Internal Ring, Peritoneal Cauterization
- What is being tested?
- Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization and Percutaneous Internal Ring Suturing
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: This is a retrospective comparative cohort study, evaluating pediatric patients who underwent Laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia between [January 2023] and [December 2024].
Who may be able to join
- Pediatric patients (3 months to 12 years) with diagnosed inguinal hernia.
- Underwent Laparoscopic Percutaneous Internal Ring Suturing (PIRS).
- Clear documentation of whether cauterization was performed.
- At least 6 months of postoperative follow-up available.
Who cannot join
- Recurrent or complicated hernias (incarcerated/strangulated).
- Previous abdominal or pelvic surgery.
- Missing or incomplete surgical records.
- Less than 6 months of follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Laparoscopic Percutaneous Extra-peritoneal Closure of Internal Ring With or Without Peritoneal Cauterization
This research project aims to evaluate pediatric patients who underwent laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia.
Read the detailed description
Inguinal hernia repair is the most common procedure performed by pediatric surgery trainees. Open hernia repair (OH) is considered the gold standard approach for children; however, laparoscopic repair (LR) has recently emerged as an alternative option.
Laparoscopic percutaneous extraperitoneal closure of internal inguinal ring (Laparoscopic Percutaneous Internal Ring Suturing) (PIRS) is one of the plainest and most dependable operations for pediatric inguinal hernia.
- Conditions
- Laparoscopic Percutaneous Extra-peritoneal Closure, Internal Ring, Peritoneal Cauterization
- Being tested
- Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization, Percutaneous Internal Ring Suturing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterizationProcedure or surgery
Percutaneous Internal Ring Suturing with peritoneal cauterization at the internal ring.
Percutaneous Internal Ring SuturingProcedure or surgery
Percutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization at the internal ring. Receives: Procedure: Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization | |
| Group B | Percutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization. Receives: Procedure: Percutaneous Internal Ring Suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrence
Incidence of recurrence was recorded.
Measured: 1 year post-procedure
Secondary outcomes (2)
Incidence of postoperative complications
Incidence of postoperative complications such as seroma, hematoma, hydrocele, and wound infection were recorded.
Measured: 24 hours postoperatively
Degree of pain
Degree of pain was assessed using Face, Legs, Activity, Cry, Consolability scale (FLACC) in patients <7 years, or using the visual analog scale (VAS)(0 represents "no pain" while 10 represents "the worst pain imaginable") in patients≥7 years.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Jan 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Percutaneous Extra-peritoneal ClosureStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mahmoud Shalaby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07102277
- Sponsor's protocol ID
- REC 713
- Status last verified
- Jul 2025
- First submitted
- 28 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Laparoscopic Percutaneous Extra-peritoneal Closure of Internal Ring With or Without Peritoneal Cauterization
- ClinicalTrials.gov ID
- NCT07102277
- Acronym / sponsor ID
- REC 713
- Conditions
- Laparoscopic Percutaneous Extra-peritoneal Closure, Internal Ring, Peritoneal Cauterization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 3 Aug 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.
This research project aims to evaluate pediatric patients who underwent laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia.
Detailed description
Inguinal hernia repair is the most common procedure performed by pediatric surgery trainees. Open hernia repair (OH) is considered the gold standard approach for children; however, laparoscopic repair (LR) has recently emerged as an alternative option.
Laparoscopic percutaneous extraperitoneal closure of internal inguinal ring (Laparoscopic Percutaneous Internal Ring Suturing) (PIRS) is one of the plainest and most dependable operations for pediatric inguinal hernia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterizationPercutaneous Internal Ring Suturing (PIRS) with peritoneal cauterization at the internal ring. |
| Group B | – | Procedure: Percutaneous Internal Ring SuturingPercutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization. |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This is a retrospective comparative cohort study, evaluating pediatric patients who underwent Laparoscopic Percutaneous Internal Ring Suturing (PIRS) for inguinal hernia between [January 2023] and [December 2024].
Key inclusion criteria (4 listed)
- Pediatric patients (3 months to 12 years) with diagnosed inguinal hernia.
- Underwent Laparoscopic Percutaneous Internal Ring Suturing (PIRS).
- Clear documentation of whether cauterization was performed.
- At least 6 months of postoperative follow-up available.
Key exclusion criteria (4 listed)
- Recurrent or complicated hernias (incarcerated/strangulated).
- Previous abdominal or pelvic surgery.
- Missing or incomplete surgical records.
- Less than 6 months of follow-up.
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 |
|---|---|---|
| Percutaneous Internal Ring Suturing (PIRS) with peritoneal cauterizationPercutaneous Internal Ring Suturing with peritoneal cauterization at the internal ring. | Procedure or surgery | Group A |
| Percutaneous Internal Ring SuturingPercutaneous Internal Ring Suturing (PIRS) without peritoneal cauterization. | Procedure or surgery | Group B |
Primary outcome
Incidence of recurrence
Time frame: 1 year post-procedure
Incidence of recurrence was recorded.
2 secondary outcomes
Incidence of postoperative complications
Time frame: 24 hours postoperatively
Degree of pain
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Percutaneous Extra-peritoneal Closure and Internal Ring, run by Tanta University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 3 Aug 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrence (time frame: 1 year post-procedure). 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 3 Aug 2025.