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

August 27, 2019 updated by: Fatima Numeri, King Edward Medical University

Comparison of Recurrence Rate of Ferguson & Gross Herniotomy With Mitchell Banks Herniotomy in Children Older Than 2 Years

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

in this study, the principal investigator will operate upon patients aged between 2 years and 12 years by two techniques. in technique called mitchell banks technique, inguinal canal will not be opened and in Fergusson gross technique, it will be opened

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • KEMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Mitchell Banks Herniotomy
Procedure: Herniotomy
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.
Other Names:
  • Mitchell Banks Herniotomy
  • Fergusson Gross Herniotomy
Experimental: Group B
Fergusson Gross Herniotomy
Procedure: Herniotomy
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.
Other Names:
  • Mitchell Banks Herniotomy
  • Fergusson Gross Herniotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 6 months
Recurrence will be assessed 6 months after the procedure
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
size of incision
Time Frame: upto 6 months, will be noted at the end of every procedure
length of incision will be noted
upto 6 months, will be noted at the end of every procedure
operation time
Time Frame: upto 6 months, will be noted at the end of every procedure
total operative time will be noted
upto 6 months, will be noted at the end of every procedure
Intra operative complications
Time Frame: upto 6 months, will be noted at the end of every procedure
Tearing of processus vaginalis, ilioinguinal nerve injury
upto 6 months, will be noted at the end of every procedure
post-operative complications
Time Frame: will be noted on follow up at 7 days post op
Wound Infection b. Scrotal Edema c. Haematoma d. TesticularRetraction
will be noted on follow up at 7 days post op
Testicular Atrophy
Time Frame: 6 months after procedure
testicular atrophy will be noted
6 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2016

Primary Completion (Actual)

January 20, 2018

Study Completion (Actual)

July 20, 2018

Study Registration Dates

First Submitted

December 8, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212/RC/KEMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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