PediatricsNCT06856304
Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia
A study testing laparoscopic disconnection of the hernia sac and Percutaneous internal ring suturing in people with Pediatrics and Inguinal Hernia Repair, run by Alexandria University at 1 site in Egypt.
Trial summary
Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Read more about this study
- Who is it for?
- Ages 6 months to 5 years, men only
- Conditions the study is for
- Pediatrics, Inguinal Hernia Repair
- What is being tested?
- laparoscopic disconnection of the hernia sac and Percutaneous internal ring suturing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 30 May 2024
- Phase
- Interventional
- 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 6 months to 5 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- male patients
- age of 6 month to 5years
- reduciable congenital inguinal hernia either unilateral or bilateral.
Who cannot join
- incarcerated CIH
- recurrent CIH
- patients with undescended testis,
- patients with hydrocele,
- patients with chronic comorbidity such as congenital heart disease and severe chest troubles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia: a Prospective Randomized Study
Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.
Read the detailed description
Introduction Since the 1990s laparoscopy has gained popularity in the management of Congenital inguinal hernia (CIH). Several laparoscopic techniques have been described, including laparoscopic disconnection of the hernial sac with narrowing of the internal ring (IIR) which was described to mimic the open technique, and the extraperitoneal approach involves using various types of needles under laparoscopic guidance to percutaneously secure a suture circumferentially around the internal ring, thus obliterating the sac opening. This study compared the short-term outcome of percutaneous internal ring suturing (PIRS) versus laparoscopic disconnection of the hernial sac with narrowing of the internal ring in children.
Materials and Methods: This study included 109 male patients with 120 CIHs during the period from May 2022 to May 2024. Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.
- Conditions
- Pediatrics, Inguinal Hernia Repair
- Being tested
- laparoscopic disconnection of the hernia sac, Percutaneous internal ring suturing
- Keywords
- Laparoscopy, inguinal hernia, PIRS, sac disconnection, Narrowing of the internal ring
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic disconnection of the hernia sacProcedure or surgery
disconnection of the hernial sac at the level of the internal ring using hook diathermy with sweeping the vas and the vessels away till completely separating them from the edges of the sac, then narrowing of the internal ring by appling a vicryl 3/0 suture between the ilipubic tract and the transverse arch of the transversus abdominus muscle
Percutaneous internal ring suturingProcedure or surgery
A single umbilical trocar was placed through a supraumbilical incision, and then the surgeon stood on the same side of the hernia. To choose the location for the needle puncture, the position of the IIR was assessed by pressing the inguinal region from the outside with the tip of a forceps. Under laparoscopic-guided vision, the previously prepared 18-gauge injection needle threaded with the monofilament suture was introduced into the abdominal wall through a skin puncture at the lateral edge of the internal ring. With the movements of the tip of the needle, the thread passed under the peritoneum, over the lateral half of the IIR. The thread was pushed through the barrel of the needle into the abdominal cavity and eventually made a loop. The needle was pulled out, leaving the loop of the thread inside the abdomen by hanging the loop on the endoscope this prevented the extraction of the loop with the needle and thus prevented repeating this step. Next, the thread loop was pulled out of t
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | laparoscopic disconnection of the hernia sac and narrowing of the internal ring Receives: Procedure: laparoscopic disconnection of the hernia sac |
| Group B | Experimental | Percautaneous internal ring suturing Receives: Procedure: Percutaneous internal ring suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
time of the procedure estimated after trocars insertion and Inflation of the abdomen till deflation of the abdomen
Measured: the time estimated during the operation
intraoperative safety
injury of the vas deffernce , spermatic vessels , bleeding
Measured: the time estimated during the operation
Recurrence of the inguinal hernia
postoperative swelling in the inguinal region with gurgling sensation
Measured: 1 year
Secondary outcomes (1)
cosmesis
postoperative scar
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start1 May 2022
- Primary completion30 May 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricsStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Abouheba, Assistant Professor, Study director, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856304
- Sponsor's protocol ID
- 0107373
- Status last verified
- Sep 2022
- First submitted
- 25 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Internal Ring Suturing Versus Conventional Laparoscopic Repair of Congenital Inguinal Hernia: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06856304
- Acronym / sponsor ID
- 0107373
- Conditions
- Pediatrics, Inguinal Hernia Repair
- Keywords
- Laparoscopy, inguinal hernia, PIRS, sac disconnection, Narrowing of the internal ring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 4 Mar 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.
Background:comparison between percutaneous internal ring suturing vs Conventional Laparoscopic Repair of Congenital Inguinal Hernia in male patients. Methods : this is a prospective randomized study including 109 male patients with 120 CIHs Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.
Detailed description
Introduction Since the 1990s laparoscopy has gained popularity in the management of Congenital inguinal hernia (CIH). Several laparoscopic techniques have been described, including laparoscopic disconnection of the hernial sac with narrowing of the internal ring (IIR) which was described to mimic the open technique, and the extraperitoneal approach involves using various types of needles under laparoscopic guidance to percutaneously secure a suture circumferentially around the internal ring, thus obliterating the sac opening. This study compared the short-term outcome of percutaneous internal ring suturing (PIRS) versus laparoscopic disconnection of the hernial sac with narrowing of the internal ring in children.
Materials and Methods: This study included 109 male patients with 120 CIHs during the period from May 2022 to May 2024. Patients were randomly categorized into two groups. Group A were subjected to laparoscopic disconnection of the hernia sac and narrowing of the internal ring (IR). Group B underwent PIRS. The intended primary outcome was recurrence within 1 year, besides comparing the two techniques regarding operative time, efficacy, safety, cosmetic outcome, and postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: laparoscopic disconnection of the hernia saclaparoscopic disconnection of the hernia sac and narrowing of the internal ring |
| Group B | Experimental | Procedure: Percutaneous internal ring suturingPercautaneous internal ring suturing |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- male patients
- age of 6 month to 5years
- reduciable congenital inguinal hernia either unilateral or bilateral.
Key exclusion criteria (5 listed)
- incarcerated CIH
- recurrent CIH
- patients with undescended testis,
- patients with hydrocele,
- patients with chronic comorbidity such as congenital heart disease and severe chest troubles
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 |
|---|---|---|
| laparoscopic disconnection of the hernia sacdisconnection of the hernial sac at the level of the internal ring using hook diathermy with sweeping the vas and the vessels away till completely separating them from the edges of the sac, then narrowing of the internal ring by appling a vicryl 3/0 suture between the ilipubic tract and the transverse arch of the transversus abdominus muscle | Procedure or surgery | Group A |
| Percutaneous internal ring suturingA single umbilical trocar was placed through a supraumbilical incision, and then the surgeon stood on the same side of the hernia. To choose the location for the needle puncture, the position of the IIR was assessed by pressing the inguinal region from the outside with the tip of a forceps. Under laparoscopic-guided vision, the previously prepared 18-gauge injection needle threaded with the monofilament suture was introduced into the abdominal wall through a skin puncture at the lateral edge of the internal ring. With the movements of the tip of the needle, the thread passed under the peritoneum, over the lateral half of the IIR. The thread was pushed through the barrel of the needle into the abdominal cavity and eventually made a loop. The needle was pulled out, leaving the loop of the thread inside the abdomen by hanging the loop on the endoscope this prevented the extraction of the loop with the needle and thus prevented repeating this step. Next, the thread loop was pulled out of t | Procedure or surgery | Group B |
Primary outcome
operative time
Time frame: the time estimated during the operation
time of the procedure estimated after trocars insertion and Inflation of the abdomen till deflation of the abdomen
intraoperative safety
Time frame: the time estimated during the operation
injury of the vas deffernce , spermatic vessels , bleeding
Recurrence of the inguinal hernia
Time frame: 1 year
postoperative swelling in the inguinal region with gurgling sensation
1 secondary outcome
cosmesis
Time frame: 1 year
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 4 Mar 2025.
- 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. This study is not recruiting at the moment.
Mohamed Abouheba, Assistant Professor study director
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic disconnection of the hernia sac and Percutaneous internal ring suturing in people with Pediatrics and Inguinal Hernia Repair, run by Alexandria 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 3 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: finished, as of the sponsor's last update on 4 Mar 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?
operative time (time frame: the time estimated during the operation). The study lists 3 primary outcomes in all. 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 4 Mar 2025.