Menu
Recruiting NCT06660550

Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics

No phase Interventional Congenital Inguinal Hernia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: laparoscopic inguinal hernia repair, Needlescopic inguinal hernia repair.
Who it may be relevant to
Registry conditions: Congenital Inguinal Hernia. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics (A Prospective Comparative Study)

Overview

The aim of the study is to evaluate the results of Needlescopic inguinal hernia repair in comparison with traditional laparoscopic repair in children as regard operative time, cosmetic appearance, recurrence and other complications.

Detailed description

Patients and methods:

* Place of the study: The study will be held in Department of Pediatric surgery in Sohag University Hospital. * Type of the study: Prospective comparative Cohort study. * Duration of the study: The study will last for 6 to 9 months starting from the date of acceptance of the protocol. * Ethical considerations: The study will be carried out after approval by scientific and ethical committees of Sohag faculty of medicine. * Method of the study:

Preoperative assessment:

1. Demographic data: e.g. name, age, sex …. etc. 2. History: e.g. complaint, present history and past surgical and medical history…etc. 3. General and local examination: e.g. laterality, associated anomalies …. etc. 4. Investigations:

Routine labs. Imaging: to confirm diagnosis in the affected side, to evaluate contralateral side, bilateral testicular volume as volumetric stander to evaluate testicular atrophy postoperative and other anomalies.

Operative technique:

Operative steps:

A. Traditional laparoscopic repair.

* STEPS:

1. A 5mm port for the camera is introduced at umbilicus by open technique. 2. Using triangulation rule to introduce two working ports. 3. The abdomen is insufflated with carbon dioxide to 6-8 mmHg pressure in patients under 1 year of age and to 8-10 mmHg in older children. 4. Diathermize the neck of the hernia sac with a diathermy hook. 5. A 10-15 cm absorbable suture is passed into the peritoneal cavity through the abdominal wall next to the lateral port under vision. 6. The purse-string stitch commences at the 2 o'clock position of the internal hernia opening. 7. ensure that a "complete ring" of peritoneum has been included in the purse-string stitch without significant gaps. 8. The purse-string suture is tied tightly using intracorporeally knot tying.

B. Needlescopic Internal Ring Suturing. * EQUIPMENT/SUTURE:

1. One 5-mm trocar and 5-mm lens 30° or 0° telescope. 2. Epidural needle. 3. Non absorbable suture. 4. Fascial closure instrument. * STEPS:

1. A 5mm port for the camera is introduced at umbilicus by open technique. 2. The abdomen is insufflated with carbon dioxide to 6-8 mmHg pressure in patients under 1 year of age and to 8-10 mmHg in older children. 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. Fascial closure instrument is introduced directly through anterior abdominal wall to help to maintain suture loop. 7. The needle is removed, leaving the loop in place. 8. 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 avoid injury. 9. The loop of suture is introduced into the hollow of the needle again and advance the suture into the first loop by the help of fascial closure. 10. Withdraw the needle. 11. Catch the suture end in the loop and withdraw them together then the suture is tied extra corporeally.

Patient outcomes:

Patients assessment and follow up:

1. Primary outcome measures:

Operative time. Intraoperative complication. Rate of conversion to open surgery. 2. Secondary outcome measures:

1 and 3 months after the surgery to asses:

1. Cosmetic appearance: according to (The Scar Cosmesis Assessment and Rating "SCAR" Scale) \[7\]. 2. Recurrence. 3. Hydrocele. 4. Testicular atrophy (postoperative imaging: \> 50% loss of testicular volume or \< 25% of volume of contralateral testis) \[8\].

Interventions

  • Procedure laparoscopic inguinal hernia repair
    traditional laparoscopic repair
  • Procedure Needlescopic inguinal hernia repair
    Needlescopic inguinal hernia repair

Primary outcome measures

  • Operative time [Time frame: during operation]
  • Intraoperative complications [Time frame: during operation]
  • Rate of conversion to open surgery. [Time frame: during operation]
Secondary outcome measures (4)
  • Cosmetic appearance [Time frame: 1 and 3 months after the surgery]
  • Recurrence [Time frame: 1 and 3 months after the surgery]
  • Hydrocele [Time frame: 1 and 3 months after the surgery]
  • Testicular atrophy [Time frame: 1 and 3 months after the surgery]

Eligibility criteria

Inclusion criteria

  • Include patients presented with inguinal hernia with age < 18 years.

Exclusion criteria

  • Age above 18 years.
  • Complicated inguinal hernia (e.g. irreducibility, obstruction and strangulation).
  • Pervious lower abdominal surgeries.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Sohag University Hospitals — Sohag

Publications

  • 1. Cóbar, J. P., & Nichol, P. F. (2023). Introduction of pediatric laparoscopic inguinal hernia repair in Guatemala. BMC Surgery, 23(1). 2. Chang, S., Chen, J. Y., Hsu, C., Chuang, F., & Yang, S. S. D. (2015). The incidence of inguinal hernia and associated risk factors of incarceration in pediatric inguinal hernia: a nation-wide longitudinal population-based study. Hernia, 20(4), 559-563. 3. Elho

Identifiers

NCT: NCT06660550 · Soh-Med-15-10-4MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗