Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years

NCT03392636 | Completed DMC

• 1 other identifier: 212/RC/KEMU
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

the study is basically aimed at comparing two techniques of herniotomy by comparing there recurrence rates

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

• recurrence

  Recurrence will be assessed 6 months after the procedure

  6 months

Secondary Outcomes (5)

• size of incision

  upto 6 months, will be noted at the end of every procedure

• operation time

  upto 6 months, will be noted at the end of every procedure

• Intra operative complications

  upto 6 months, will be noted at the end of every procedure

• post-operative complications

  will be noted on follow up at 7 days post op

• Testicular Atrophy

  6 months after procedure

Study Arms (2)

Group A

EXPERIMENTAL

Mitchell Banks Herniotomy

Procedure: Herniotomy

Group B

EXPERIMENTAL

Fergusson Gross Herniotomy

Procedure: Herniotomy

Interventions

Herniotomy PROCEDURE

In Mitchell Banks Herniotomy, one of investigators will do herniotomy without opening inguinal canal and in Ferguson Gross Herniotomy , one of investigators will do herniotmy by opening inguinal canal.

Also known as: Mitchell Banks Herniotomy, Fergusson Gross Herniotomy

Group A; Group B

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All pediatric patients of either gender above age of 2 years and below 14 years of age presenting in pediatric surgery Mayo hospital lahore

You may not qualify if:

• sliding hernia strangulated hernia pts with connective tissue disorders pts with undesccended testis patients with hydrocele hernia with internal ring 2cm or more in size

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

KEMU

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant professor

Model Details: Group A will get Mitchell Banks herniotomy done and Group B will get Fergusson Gross Herniotomy done.

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: January 8, 2018
• Study Start: November 11, 2016
• Primary Completion: January 20, 2018
• Study Completion: July 20, 2018
• Last Updated: August 28, 2019

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)