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NCT06356987 Clinical Trial

Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children

Inguinal Hernia Clinical Trial

— Herniotomy  

Official title:
Comparison of Laparoscopic Extraperitoneal Closure and Open Herniotomy in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06356987
Other study ID # 0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 31, 2021

Study information
Verified date April 2024
Source King Edward Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Months to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Herniotomy
In Group A Laparoscopic assisted needle herniotomy was done

Locations
Country Name City State
Pakistan Muhammad Sharif Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Operative time Operative time was noted in both groups. 3 months
Primary Recurrence recurrence was also noted in both groups 3 Month
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