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OpenTrials
Completed

NCT Number: NCT06936423

Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy

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

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, 11517, Egypt

About this study

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:

A) 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.

B) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open herniotomy

Procedure

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

Needlescopic percutaneous Internal ring suturing

Procedure

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

Primary outcomes

  1. Intraoperative outcomes

    Time frame: From the start of anesthesia till the end of operation

    Operative time. / Intraoperative complication. / Rate of conversion to open surgery.

  2. 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.

  3. 2nd post-operative visit

    Time frame: After 1 month post operative

    For assessment of : Cosmetic appearance. Recurrence. Hydrocele if present

  4. 3rd post-operative visit

    Time frame: After 3 month post operative

    tfor assessment of : Cosmetic appearance. Recurrence. Hydrocele

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: Needlescopic

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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