Comparative Study of Needlescopic Inguinal Hernia Repair Versus Open Herniotomy

NCT06936423 | Completed DMC

• 1 other identifier: No.IRB 00006379
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Indirect Inguinal Hernia; Pediatric

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Open herniotomy Group

ACTIVE COMPARATOR

Procedure: Open herniotomy

Needlescopic percutaneous Internal Ring Suturing group

ACTIVE COMPARATOR

Procedure: Needlescopic percutaneous Internal ring suturing

Interventions

Open herniotomy PROCEDURE

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

Open herniotomy Group

Needlescopic percutaneous Internal ring suturing PROCEDURE

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

Needlescopic percutaneous Internal Ring Suturing group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Male or female patients. 2. Age between 4 to 12 years. 3. Bilateral or unilateral indirect inguinal hernia

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11517, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: April 20, 2025
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: April 20, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before may 2025
• Access Criteria: Free

Locations

EG (1)