Indirect Inguinal HerniaNeedlescopicNCT06936423
Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy
A study testing Open herniotomy and Needlescopic percutaneous Internal ring suturing in people with Indirect Inguinal Hernia and Pediatric, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to compare between two techniques to treat hernia in children which are Needlescopic inguinal hernia repair and Open classic surgery as regard operative time, cosmetic appearance, recurrence and other complications Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Indirect Inguinal Hernia, Pediatric
- What is being tested?
- Open herniotomy and Needlescopic percutaneous Internal ring suturing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Sep 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Male or female patients. 2. Age between 4 to 12 years. 3. Bilateral or unilateral indirect inguinal hernia
Who cannot join
- 1. Age below 4 year and above 12 years. 2. Irreducible inguinal hernia. 3. Recurrent inguinal hernia. 4. Patient not fit for Laparoscopic Surgery. 5. Direct inguinal hernia. 6. Sliding type of indirect inguinal hernia. 7. Double pathology like associated undescended testis, vaginal hydrocele, encysted hydrocele and hydrocele of canal of Nuck.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring Efficacy and Safety: A Comparative Prospective Cohort Study Of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy In Pediatrics
This study aims to compare between two techniques to treat hernia in children which are Needlescopic inguinal hernia repair and Open classic surgery as regard operative time, cosmetic appearance, recurrence and other complications
Read the detailed description
Study Procedures:
Preoperative assessment :
- Detailed history including age, sex, complain (groin swelling increasing in size with cough and crying) and past surgical and medical history.
- General and local examination including reducible swelling forwards, upwards and laterally (inguinoscrotal in males and inguinal in females). If any sign or symptoms of irreducibility or strangulation present (abdominal distention, vomiting, constipation, tense, tender or erythematous inguinal swelling) patient should be excluded.
- Investigations: Inguinal ultrasound is only done in cases of query history or uncertain examination or to exclude bilateral pathology.
- Preoperative preparation included complete blood count, coagulation profile and complete fasting hours.
Operative technique:
Anaesthesia: General anaesthesia using endotracheal intubation and muscle relaxant plus local anaesthesia in the form of caudal block.
Position: supine. Sterilization of operative field from Xiphisternal joint to mid-thigh by Povidone-iodine solution.
Operative steps:
- Needlescopic Internal Ring Suturing with Epidural needle.
EQUIPMENT/SUTURE:
- One 5-mm trocar and 5-mm lens 30° or 0° laparoscopy.
- Epidural needle.
- Prolene 2-0 suture.
STEPS:
- A 5mm port for the camera is introduced at umbilicus.
- Hydrostatic dissection of the peritoneum of the cord structures is done by injecting saline in males.
- The suture is introduced through the barrel of the epidural needle.
- Maintaining both ends of the preloaded suture extra peritoneal, the needle is advanced under the peritoneum around lateral half of the internal ring.
- The peritoneum is entered and the suture advanced into the abdominal cavity, creating a loop.
- The needle is removed, leaving the loop in place.
- The needle is entered again through the same skin puncture site around the medial half of the ring and enter the peritoneum, leaving a small space above the vas deferens and testicular vessels to prevent injury.
- The loop of suture is introduced into the hollow of the needle again and advance the suture into the first loop.
- Withdraw the needle.
- Catch the suture end in the loop and withdraw them together then the suture is tied extra corporeally.
- Open surgery repair:
- Groin incision.
- Dissecting the hernia sac from the spermatic cord in males.
- Suture tightening of the hernia sac base. The Patients will be discharged after 4 hours post-operative.
- Conditions
- Indirect Inguinal Hernia, Pediatric
- Being tested
- Open herniotomy, Needlescopic percutaneous Internal ring suturing
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open herniotomyProcedure or surgery
Open inguinal herniotomy through inguinal incision then dissection and separation/ligation of the hernial sac
Needlescopic percutaneous Internal ring suturingProcedure or surgery
Laparoscopic extracorporeal percutaneous Internal ring suturing using epidural needle and prolene/ethibond suture
| Study group | Role | What they receive |
|---|---|---|
| Open herniotomy Group | Active comparator | Not described Receives: Procedure: Open herniotomy |
| Needlescopic percutaneous Internal Ring Suturing group | Active comparator | Not described Receives: Procedure: Needlescopic percutaneous Internal ring suturing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative outcomes
Operative time. / Intraoperative complication. / Rate of conversion to open surgery.
Measured: From the start of anesthesia till the end of operation
1st Post-operative visit
for removal of wound dressing and assessment of wound for infection if present or recurrence.
Measured: After 1 week post operative
2nd post-operative visit
For assessment of : Cosmetic appearance. Recurrence. Hydrocele if present
Measured: After 1 month post operative
3rd post-operative visit
tfor assessment of : Cosmetic appearance. Recurrence. Hydrocele
Measured: After 3 month post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indirect Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936423
- Sponsor's protocol ID
- No.IRB 00006379
- Acronym
- Needlescopic
- Status last verified
- Jan 2024
- First submitted
- 13 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completed
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Efficacy and Safety: A Comparative Prospective Cohort Study Of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy In Pediatrics
- ClinicalTrials.gov ID
- NCT06936423
- Acronym / sponsor ID
- Needlescopic / No.IRB 00006379
- Conditions
- Indirect Inguinal Hernia, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 20 Apr 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 study aims to compare between two techniques to treat hernia in children which are Needlescopic inguinal hernia repair and Open classic surgery as regard operative time, cosmetic appearance, recurrence and other complications
Detailed description
Study Procedures:
Preoperative assessment :
- Detailed history including age, sex, complain (groin swelling increasing in size with cough and crying) and past surgical and medical history.
- General and local examination including reducible swelling forwards, upwards and laterally (inguinoscrotal in males and inguinal in females). If any sign or symptoms of irreducibility or strangulation present (abdominal distention, vomiting, constipation, tense, tender or erythematous inguinal swelling) patient should be excluded.
- Investigations: Inguinal ultrasound is only done in cases of query history or uncertain examination or to exclude bilateral pathology.
- Preoperative preparation included complete blood count, coagulation profile and complete fasting hours.
Operative technique:
Anaesthesia: General anaesthesia using endotracheal intubation and muscle relaxant plus local anaesthesia in the form of caudal block.
Position: supine. Sterilization of operative field from Xiphisternal joint to mid-thigh by Povidone-iodine solution.
Operative steps:
- Needlescopic Internal Ring Suturing with Epidural needle.
EQUIPMENT/SUTURE:
- One 5-mm trocar and 5-mm lens 30° or 0° laparoscopy.
- Epidural needle.
- Prolene 2-0 suture.
STEPS:
- A 5mm port for the camera is introduced at umbilicus.
- Hydrostatic dissection of the peritoneum of the cord structures is done by injecting saline in males.
- The suture is introduced through the barrel of the epidural needle.
- Maintaining both ends of the preloaded suture extra peritoneal, the needle is advanced under the peritoneum around lateral half of the internal ring.
- The peritoneum is entered and the suture advanced into the abdominal cavity, creating a loop.
- The needle is removed, leaving the loop in place.
- The needle is entered again through the same skin puncture site around the medial half of the ring and enter the peritoneum, leaving a small space above the vas deferens and testicular vessels to prevent injury.
- The loop of suture is introduced into the hollow of the needle again and advance the suture into the first loop.
- Withdraw the needle.
- Catch the suture end in the loop and withdraw them together then the suture is tied extra corporeally.
- Open surgery repair:
- Groin incision.
- Dissecting the hernia sac from the spermatic cord in males.
- Suture tightening of the hernia sac base. The Patients will be discharged after 4 hours post-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open herniotomy Group | Active comparator | Procedure: Open herniotomy |
| Needlescopic percutaneous Internal Ring Suturing group | Active comparator | Procedure: Needlescopic percutaneous Internal ring suturing |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Male or female patients. 2. Age between 4 to 12 years. 3. Bilateral or unilateral indirect inguinal hernia
Key exclusion criteria (1 listed)
- 1. Age below 4 year and above 12 years. 2. Irreducible inguinal hernia. 3. Recurrent inguinal hernia. 4. Patient not fit for Laparoscopic Surgery. 5. Direct inguinal hernia. 6. Sliding type of indirect inguinal hernia. 7. Double pathology like associated undescended testis, vaginal hydrocele, encysted hydrocele and hydrocele of canal of Nuck.
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 |
|---|---|---|
| Open herniotomyOpen inguinal herniotomy through inguinal incision then dissection and separation/ligation of the hernial sac | Procedure or surgery | Open herniotomy Group |
| Needlescopic percutaneous Internal ring suturingLaparoscopic extracorporeal percutaneous Internal ring suturing using epidural needle and prolene/ethibond suture | Procedure or surgery | Needlescopic percutaneous Internal Ring Suturing group |
Primary outcome
Intraoperative outcomes
Time frame: From the start of anesthesia till the end of operation
Operative time. / Intraoperative complication. / Rate of conversion to open surgery.
1st Post-operative visit
Time frame: After 1 week post operative
for removal of wound dressing and assessment of wound for infection if present or recurrence.
2nd post-operative visit
Time frame: After 1 month post operative
For assessment of : Cosmetic appearance. Recurrence. Hydrocele if present
3rd post-operative visit
Time frame: After 3 month post operative
tfor assessment of : Cosmetic appearance. Recurrence. Hydrocele
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 20 Apr 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completed
Related trials for Indirect Inguinal Hernia
Active, not recruiting
Evaluating the Efficacy and Safety of a New Laparoscopic Non-mesh Hernia Needle Set Designed for Indirect Inguinal Hernia
Inguinal Hernia, Without Mention of Obstruction or Gangrene
Recruiting
Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair
Indirect Inguinal Hernia
Active, not recruitingObservational study
INVESTIGATION OF THE GENETIC ETIOLOGY OF HERNIA SAC DEVELOPMENT IN MALE CHILDREN WITH UNDESCENDED TESTIS AND INGUINAL HERNIA
Indirect Inguinal Hernia, Undescended Testis
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?
A study testing Open herniotomy and Needlescopic percutaneous Internal ring suturing in people with Indirect Inguinal Hernia and Pediatric, run by Ain Shams 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 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: finished, as of the sponsor's last update on 20 Apr 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?
Intraoperative outcomes (time frame: From the start of anesthesia till the end of operation). 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?
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 20 Apr 2025.