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OpenTrials
Completed

NCT Number: NCT06356987

Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children

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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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad Sharif

Lahore, Punjab Province, 53711, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with recurrent inguinal hernia, hydrocele, hernia with undescended testes and Sliding hernia diagnosed on history, clinical examination and investigations.
  • Patients with complicated hernia (e.g. incarcerated ovary), irreducible or obstructed inguinal hernia diagnosed on history, clinical examination and investigations.
  • Patients who cannot tolerate pneumoperitoneum or general anaesthesia.
  • Patients with congenital heart disease, other co-morbid conditions.

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Treatment and study plan

Herniotomy

Procedure

In Group A Laparoscopic assisted needle herniotomy was done

Other names: Laparoscopic herniotomy

Primary outcomes

  1. Operative time

    Time frame: 3 months

    Operative time was noted in both groups.

  2. Recurrence

    Time frame: 3 Month

    recurrence was also noted in both groups

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

Comparison of Laparoscopic Extraperitoneal Closure and Open Herniotomy in Children

Acronym: Herniotomy

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 10, 2024
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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