Clinical trial NCT06356987: Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children
Official title: Comparison of Laparoscopic Extraperitoneal Closure and Open Herniotomy in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Laparoscopic herniotomy
Open herniotomy,
Inguinal Hernia
Children
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 66 patients with inguinal hernia were randomly divided into two groups (A and B)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Operative time
timeFrame: 3 months
measure: Recurrence
timeFrame: 3 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Muhammad Sharif
state: Punjab
Study officials:
affiliation: King edward Medical University/Mayo Hospital Lahore
name: Muhammad Sharif
role: STUDY_CHAIR
References: