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Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy

Exploring Efficacy and Safety: A Comparative Prospective Cohort Study Of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy In Pediatrics

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06936423
Acronym
Needlescopic
Enrollment
43
Registered
2025-04-20
Start date
2024-01-01
Completion date
2024-09-30
Last updated
2025-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indirect Inguinal Hernia, Pediatric

Brief 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

Detailed description

Study Procedures: Preoperative assessment : 1. Detailed history including age, sex, complain (groin swelling increasing in size with cough and crying) and past surgical and medical history. 2. 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. 3. Investigations: Inguinal ultrasound is only done in cases of query history or uncertain examination or to exclude bilateral pathology. 4. 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: A) Needlescopic Internal Ring Suturing with Epidural needle. EQUIPMENT/SUTURE: 1. One 5-mm trocar and 5-mm lens 30° or 0° laparoscopy. 2. Epidural needle. 3. Prolene 2-0 suture. STEPS: 1. A 5mm port for the camera is introduced at umbilicus. 2. Hydrostatic dissection of the peritoneum of the cord structures is done by injecting saline in males. 3. The suture is introduced through the barrel of the epidural needle. 4. Maintaining both ends of the preloaded suture extra peritoneal, the needle is advanced under the peritoneum around lateral half of the internal ring. 5. The peritoneum is entered and the suture advanced into the abdominal cavity, creating a loop. 6. The needle is removed, leaving the loop in place. 7. 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. 8. The loop of suture is introduced into the hollow of the needle again and advance the suture into the first loop. 9. Withdraw the needle. 10. Catch the suture end in the loop and withdraw them together then the suture is tied extra corporeally. B) Open surgery repair: 1. Groin incision. 2. Dissecting the hernia sac from the spermatic cord in males. 3. Suture tightening of the hernia sac base. The Patients will be discharged after 4 hours post-operative.

Interventions

PROCEDUREOpen herniotomy

Open inguinal herniotomy through inguinal incision then dissection and separation/ligation of the hernial sac

PROCEDURENeedlescopic percutaneous Internal ring suturing

Laparoscopic extracorporeal percutaneous Internal ring suturing using epidural needle and prolene/ethibond suture

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* 1\. Male or female patients. 2. Age between 4 to 12 years. 3. Bilateral or unilateral indirect inguinal hernia

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative outcomesFrom the start of anesthesia till the end of operationOperative time. / Intraoperative complication. / Rate of conversion to open surgery.
1st Post-operative visitAfter 1 week post operativefor removal of wound dressing and assessment of wound for infection if present or recurrence.
2nd post-operative visitAfter 1 month post operativeFor assessment of : Cosmetic appearance. Recurrence. Hydrocele if present
3rd post-operative visitAfter 3 month post operativetfor assessment of : Cosmetic appearance. Recurrence. Hydrocele

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026