Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06660550

Needlescopic Versus Traditional Laparoscopic Inguinal Hernia Repair in Pediatrics

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

  • Demographic data: e.g. name, age, sex …. etc.
  • History: e.g. complaint, present history and past surgical and medical history…etc.
  • General and local examination: e.g. laterality, associated anomalies …. etc.
  • 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:
  • A 5mm port for the camera is introduced at umbilicus by open technique.
  • Using triangulation rule to introduce two working ports.
  • 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.
  • Diathermize the neck of the hernia sac with a diathermy hook.
  • A 10-15 cm absorbable suture is passed into the peritoneal cavity through the abdominal wall next to the lateral port under vision.
  • The purse-string stitch commences at the 2 o'clock position of the internal hernia opening.
  • ensure that a "complete ring" of peritoneum has been included in the purse-string stitch without significant gaps.
  • The purse-string suture is tied tightly using intracorporeally knot tying.

B. Needlescopic Internal Ring Suturing.

  • EQUIPMENT/SUTURE:
  • One 5-mm trocar and 5-mm lens 30° or 0° telescope.
  • Epidural needle.
  • Non absorbable suture.
  • Fascial closure instrument.
  • STEPS:
  • A 5mm port for the camera is introduced at umbilicus by open technique.
  • 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.
  • 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.
  • Fascial closure instrument is introduced directly through anterior abdominal wall to help to maintain suture 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 avoid injury.
  • 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.
  • Withdraw the needle.
  • 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:

  • Primary outcome measures:

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

  • Secondary outcome measures:

1 and 3 months after the surgery to asses:

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Laparoscopic Inguinal Hernia Repair

Procedure

traditional laparoscopic repair

Needlescopic inguinal hernia repair

Procedure

Needlescopic inguinal hernia repair

Primary outcomes

  1. Operative time

    Time frame: during operation

    Operative time from start of incision making till end of operation and closure of incisions

  2. Intraoperative complications

    Time frame: during operation

    as injury to inferior epigastric vessels, vas deferens and major pelvic vessels

  3. Rate of conversion to open surgery.

    Time frame: during operation

    rate of conversion from laparoscopic surgery to open surgery.

Secondary outcomes

  1. Cosmetic appearance

    Time frame: 1 and 3 months after the surgery

    according to (The Scar Cosmesis Assessment and Rating "SCAR" Scale)

  2. Recurrence

    Time frame: 1 and 3 months after the surgery

    recurrence of inguinal hernia diagnosed clinically and/or by ultrasound

  3. Hydrocele

    Time frame: 1 and 3 months after the surgery

    diagnosed clinically and/or by ultrasound

  4. Testicular atrophy

    Time frame: 1 and 3 months after the surgery

    diagnosed clinically and/or by ultrasound (postoperative imaging: > 50% loss of testicular volume or < 25% of volume of contralateral testis).

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelaziz A Abdelaziz, Resident

CONTACT

[email protected]

00201010274505

Ahmed M Abd El-Moniem, Professor

CONTACT

00201005768450

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Nov 27, 2024

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.

Published trials that share one or more normalized conditions with this study.