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

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Herniotomy
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

2 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • KEMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Mitchell Banks Herniotomy

Fergusson Gross Herniotomy

Outcomes

Primary Outcome Measures

recurrence
Recurrence will be assessed 6 months after the procedure

Secondary Outcome Measures

size of incision
length of incision will be noted
operation time
total operative time will be noted
Intra operative complications
Tearing of processus vaginalis, ilioinguinal nerve injury
post-operative complications
Wound Infection b. Scrotal Edema c. Haematoma d. TesticularRetraction
Testicular Atrophy
testicular atrophy will be noted

Full Information

First Posted
December 8, 2017
Last Updated
August 27, 2019
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03392636
Brief Title
Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years
Official Title
Comparison of Recurrence Rate of Ferguson & Gross Herniotomy With Mitchell Banks Herniotomy in Children Older Than 2 Years
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2016 (Actual)
Primary Completion Date
January 20, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group A will get Mitchell Banks herniotomy done and Group B will get Fergusson Gross Herniotomy done.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Mitchell Banks Herniotomy
Arm Title
Group B
Arm Type
Experimental
Arm Description
Fergusson Gross Herniotomy
Intervention Type
Procedure
Intervention Name(s)
Herniotomy
Other Intervention Name(s)
Mitchell Banks Herniotomy, Fergusson Gross Herniotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
recurrence
Description
Recurrence will be assessed 6 months after the procedure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
size of incision
Description
length of incision will be noted
Time Frame
upto 6 months, will be noted at the end of every procedure
Title
operation time
Description
total operative time will be noted
Time Frame
upto 6 months, will be noted at the end of every procedure
Title
Intra operative complications
Description
Tearing of processus vaginalis, ilioinguinal nerve injury
Time Frame
upto 6 months, will be noted at the end of every procedure
Title
post-operative complications
Description
Wound Infection b. Scrotal Edema c. Haematoma d. TesticularRetraction
Time Frame
will be noted on follow up at 7 days post op
Title
Testicular Atrophy
Description
testicular atrophy will be noted
Time Frame
6 months after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
KEMU
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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