Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children

NCT06356987 | Completed

• 1 other identifier: 0002
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Inguinal Hernia

Keywords

Laparoscopic herniotomy; Open herniotomy,; Inguinal Hernia; Children

Outcome Measures

Primary Outcomes (2)

• Operative time

  Operative time was noted in both groups.

  3 months

• Recurrence

  recurrence was also noted in both groups

  3 Month

Study Arms (2)

Group-A: Laparoscopic hernia repair

EXPERIMENTAL

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

Procedure: Herniotomy

Group B open herniotomy

ACTIVE COMPARATOR

In group B(33 patients) open herniotomy was done

Procedure: Herniotomy

Interventions

Herniotomy PROCEDURE

In Group A Laparoscopic assisted needle herniotomy was done

Also known as: Laparoscopic herniotomy

Group B open herniotomy; Group-A: Laparoscopic hernia repair

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Muhammad Sharif

Lahore, Punjab Province, 53711, Pakistan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Sharif

  King edward Medical University/Mayo Hospital Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 66 patients (33 patients in each group) of laparoscopic extraperitoneal closure and open herniotomy each
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

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

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 10, 2024
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)