Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

66 patients with inguinal hernia were randomly divided into two groups (A and B)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

66 patients (33 patients in each group) of laparoscopic extraperitoneal closure and open herniotomy each

Study Groups

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Group-A: Laparoscopic hernia repair

In group A (33 patients) laparoscopic assisted needle herniotomy was done

Group Type EXPERIMENTAL

Herniotomy

Intervention Type PROCEDURE

In Group A Laparoscopic assisted needle herniotomy was done

Group B open herniotomy

In group B(33 patients) open herniotomy was done

Group Type ACTIVE_COMPARATOR

Herniotomy

Intervention Type PROCEDURE

In Group A Laparoscopic assisted needle herniotomy was done

Interventions

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Herniotomy

In Group A Laparoscopic assisted needle herniotomy was done

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic herniotomy

Eligibility Criteria

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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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Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No