Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy (Needlescopic)

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

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

Study Overview

• Status: Completed
• Conditions: Pediatric; Indirect Inguinal Hernia
• Intervention / Treatment: Procedure: Open herniotomy; Procedure: Needlescopic percutaneous Internal ring suturing

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Open herniotomy Group	Procedure: Open herniotomy; Open inguinal herniotomy through inguinal incision then dissection and separation/ligation of the hernial sac
Active Comparator: Needlescopic percutaneous Internal Ring Suturing group	Procedure: Needlescopic percutaneous Internal ring suturing; Laparoscopic extracorporeal percutaneous Internal ring suturing using epidural needle and prolene/ethibond suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative outcomes	Operative time. / Intraoperative complication. / Rate of conversion to open surgery.	From the start of anesthesia till the end of operation
1st Post-operative visit	for removal of wound dressing and assessment of wound for infection if present or recurrence.	After 1 week post operative
2nd post-operative visit	For assessment of : Cosmetic appearance. Recurrence. Hydrocele if present	After 1 month post operative
3rd post-operative visit	tfor assessment of : Cosmetic appearance. Recurrence. Hydrocele	After 3 month post operative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: No.IRB 00006379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be shared once study is completed
• IPD Sharing Time Frame: Before may 2025
• IPD Sharing Access Criteria: Free
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No