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Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy

A

Ain Shams University

Status

Completed

Conditions

Indirect Inguinal Hernia
Pediatric

Treatments

Procedure: Needlescopic percutaneous Internal ring suturing
Procedure: Open herniotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT06936423
No.IRB 00006379

Details and patient eligibility

About

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

Full 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.

Enrollment

43 patients

Sex

All

Ages

4 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

43 participants in 2 patient groups

Open herniotomy Group
Active Comparator group
Treatment:
Procedure: Open herniotomy
Needlescopic percutaneous Internal Ring Suturing group
Active Comparator group
Treatment:
Procedure: Needlescopic percutaneous Internal ring suturing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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