Hernia, InguinalNCT03392636
Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years
A study testing Herniotomy in people with Hernia, Inguinal, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
the study is basically aimed at comparing two techniques of herniotomy by comparing there recurrence rates Read more about this study
- Who is it for?
- Ages 2 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Herniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Nov 2016to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All pediatric patients of either gender above age of 2 years and below 14 years of age presenting in pediatric surgery Mayo hospital lahore
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Hernia, Inguinal
- Being tested
- Herniotomy
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HerniotomyProcedure or surgery
Also called Mitchell Banks Herniotomy, Fergusson Gross 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Mitchell Banks Herniotomy Receives: Procedure: Herniotomy |
| Group B | Experimental | Fergusson Gross Herniotomy Receives: Procedure: Herniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
Recurrence will be assessed 6 months after the procedure
Measured: 6 months
Secondary outcomes (5)
size of incision
length of incision will be noted
Measured: upto 6 months, will be noted at the end of every procedure
operation time
total operative time will be noted
Measured: upto 6 months, will be noted at the end of every procedure
Intra operative complications
Tearing of processus vaginalis, ilioinguinal nerve injury
Measured: upto 6 months, will be noted at the end of every procedure
post-operative complications
Wound Infection b. Scrotal Edema c. Haematoma d. TesticularRetraction
Measured: will be noted on follow up at 7 days post op
Testicular Atrophy
testicular atrophy will be noted
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start11 Nov 2016
- Primary completion20 Jan 2018
- Study completion20 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will get Mitchell Banks herniotomy done and Group B will get Fergusson Gross Herniotomy done.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Numeri, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392636
- Sponsor's protocol ID
- 212/RC/KEMU
- Status last verified
- Mar 2018
- First submitted
- 8 Dec 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Recurrence Rate of Ferguson & Gross Herniotomy With Mitchell Banks Herniotomy in Children Older Than 2 Years
- ClinicalTrials.gov ID
- NCT03392636
- Acronym / sponsor ID
- 212/RC/KEMU
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 20 Jan 2018 (actual)
- Study completion
- 20 Jul 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will get Mitchell Banks herniotomy done and Group B will get Fergusson Gross Herniotomy done.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: HerniotomyMitchell Banks Herniotomy |
| Group B | Experimental | Procedure: HerniotomyFergusson Gross Herniotomy |
Who may qualify
- Ages
- 2 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All pediatric patients of either gender above age of 2 years and below 14 years of age presenting in pediatric surgery Mayo hospital lahore
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HerniotomyAlso: Mitchell Banks Herniotomy, Fergusson Gross HerniotomyIn 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. | Procedure or surgery | Group A, Group B |
Primary outcome
recurrence
Time frame: 6 months
Recurrence will be assessed 6 months after the procedure
5 secondary outcomes
size of incision
Time frame: 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
Intra operative complications
Time frame: 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
Testicular Atrophy
Time frame: 6 months after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herniotomy in people with Hernia, Inguinal, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.