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

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03392636
• Other study ID #: 212/RC/KEMU
• Status: Completed
• Phase: N/A
• Start date: November 11, 2016
• Est. completion date: July 20, 2018

Study information

• Verified date: March 2018
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: July 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Inguinal
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
Pakistan	KEMU	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

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