Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Herniotomy

• Registration Number: NCT06356987
• Lead Sponsor: King Edward Medical University

Brief Summary

All patients of age 6 month to 12 years with inguinal hernia were included in study.

Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications

Detailed Description

BACKGROUND: The best method of inguinal hernia repair in children continues to be a topic of debate. Although recent data shows that LPEC is superior and safe but no such data exists in our country. Operative time and recurrence are main concerns. Hence, present study is carried out to compare outcome of LPEC versus OHR in children.

OBJECTIVE: To compare the outcome of laparoscopic percutaneous extra-peritoneal closure and open repair for inguinal hernia in children METHODOLOGY: It was a randomized control trial conducted on 66 patients (33 in each group) presented to our hospital with features of Inguinal Hernia. Patients were admitted after confirmation of diagnosis by ultrasound and complete blood count (CBC) was sent. Pre operatively patients were divided in two groups randomly (Open Hernia Repair group, LPEC group) by closed envelope method. Consent was taken from parents regarding inclusion in the study. All demographic data and results were noted down in a proforma. The collected data was entered and analyzed in computer software SPSS (Statistical Package for Social Sciences) version 26.0.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2024-03-30
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-04
• Study First Posted: 2024-04-10
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

All patients of age 6 months to 12 years of either gender having unilateral or bilateral inguinal hernia diagnosed on history, clinical examination and investigations.

Exclusion Criteria

1. Patients with recurrent inguinal hernia, hydrocele, hernia with undescended testes and Sliding hernia diagnosed on history, clinical examination and investigations.

2. Patients with complicated hernia (e.g. incarcerated ovary), irreducible or obstructed inguinal hernia diagnosed on history, clinical examination and investigations.

3. Patients who cannot tolerate pneumoperitoneum or general anaesthesia.

4. Patients with congenital heart disease, other co-morbid conditions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B open herniotomy	Herniotomy	In group B(33 patients) open herniotomy was done
Group-A: Laparoscopic hernia repair	Herniotomy	In group A (33 patients) laparoscopic assisted needle herniotomy was done

Primary Outcome Measures

Name	Time	Method
Operative time	3 months	Operative time was noted in both groups.
Recurrence	3 Month	recurrence was also noted in both groups

Trial Locations

Locations (1)

Muhammad Sharif; 🇵🇰 Lahore, Punjab, Pakistan