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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03392636
Other study ID # 212/RC/KEMU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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