Clinical trial NCT06936423: Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy
Official title: Exploring Efficacy and Safety: A Comparative Prospective Cohort Study Of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy In Pediatrics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Indirect Inguinal Hernia
Pediatric
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 43
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Intraoperative outcomes
timeFrame: From the start of anesthesia till the end of operation
measure: 1st Post-operative visit
timeFrame: After 1 week post operative
measure: 2nd post-operative visit
timeFrame: After 1 month post operative
measure: 3rd post-operative visit
timeFrame: After 3 month post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References: