Inguinal HerniaHerniotomyNCT06356987
Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children
A study testing Herniotomy in people with Inguinal Hernia, run by King Edward Medical University at 1 site in Pakistan.
Trial summary
All patients of age 6 month to 12 years with inguinal hernia were included in study. Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Inguinal Hernia
- 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
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients of age 6 months to 12 years of either gender having unilateral or bilateral inguinal hernia diagnosed on history, clinical examination and investigations.
Who cannot join
- Patients with recurrent inguinal hernia, hydrocele, hernia with undescended testes and Sliding hernia diagnosed on history, clinical examination and investigations.
- Patients with complicated hernia (e.g. incarcerated ovary), irreducible or obstructed inguinal hernia diagnosed on history, clinical examination and investigations.
- Patients who cannot tolerate pneumoperitoneum or general anaesthesia.
- Patients with congenital heart disease, other co-morbid conditions.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Laparoscopic Extraperitoneal Closure and Open Herniotomy in Children
All patients of age 6 month to 12 years with inguinal hernia were included in study.
Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications
Read the detailed description
BACKGROUND: The best method of inguinal hernia repair in children continues to be a topic of debate. Although recent data shows that LPEC is superior and safe but no such data exists in our country. Operative time and recurrence are main concerns. Hence, present study is carried out to compare outcome of LPEC versus OHR in children.
OBJECTIVE: To compare the outcome of laparoscopic percutaneous extra-peritoneal closure and open repair for inguinal hernia in children METHODOLOGY: It was a randomized control trial conducted on 66 patients (33 in each group) presented to our hospital with features of Inguinal Hernia. Patients were admitted after confirmation of diagnosis by ultrasound and complete blood count (CBC) was sent. Pre operatively patients were divided in two groups randomly (Open Hernia Repair group, LPEC group) by closed envelope method. Consent was taken from parents regarding inclusion in the study. All demographic data and results were noted down in a proforma. The collected data was entered and analyzed in computer software SPSS (Statistical Package for Social Sciences) version 26.0.
- Conditions
- Inguinal Hernia
- Being tested
- Herniotomy
- Keywords
- Laparoscopic herniotomy, Open herniotomy,, Inguinal Hernia, Children
- 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 Laparoscopic herniotomy
In Group A Laparoscopic assisted needle herniotomy was done
| Study group | Role | What they receive |
|---|---|---|
| Group-A: Laparoscopic hernia repair | Experimental | In group A (33 patients) laparoscopic assisted needle herniotomy was done Receives: Procedure: Herniotomy |
| Group B open herniotomy | Active comparator | In group B(33 patients) open herniotomy was done Receives: Procedure: Herniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time was noted in both groups.
Measured: 3 months
Recurrence
recurrence was also noted in both groups
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jun 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- 66 patients with inguinal hernia were randomly divided into two groups (A and B)
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Sharif, King Edward Medical University
- Investigators
- Muhammad Sharif, Study chair, King edward Medical University/Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06356987
- Sponsor's protocol ID
- 0002
- Acronym
- Herniotomy
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: plan to share on demand
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Extraperitoneal Closure and Open Herniotomy in Children
- ClinicalTrials.gov ID
- NCT06356987
- Acronym / sponsor ID
- Herniotomy / 0002
- Conditions
- Inguinal Hernia
- Keywords
- Laparoscopic herniotomy, Open herniotomy,, Inguinal Hernia, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Apr 2024 (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.
All patients of age 6 month to 12 years with inguinal hernia were included in study.
Data was collected on detailed proforma regarding age, sex, side ,operative time, cosmesis , and postoperative complications
Detailed description
BACKGROUND: The best method of inguinal hernia repair in children continues to be a topic of debate. Although recent data shows that LPEC is superior and safe but no such data exists in our country. Operative time and recurrence are main concerns. Hence, present study is carried out to compare outcome of LPEC versus OHR in children.
OBJECTIVE: To compare the outcome of laparoscopic percutaneous extra-peritoneal closure and open repair for inguinal hernia in children METHODOLOGY: It was a randomized control trial conducted on 66 patients (33 in each group) presented to our hospital with features of Inguinal Hernia. Patients were admitted after confirmation of diagnosis by ultrasound and complete blood count (CBC) was sent. Pre operatively patients were divided in two groups randomly (Open Hernia Repair group, LPEC group) by closed envelope method. Consent was taken from parents regarding inclusion in the study. All demographic data and results were noted down in a proforma. The collected data was entered and analyzed in computer software SPSS (Statistical Package for Social Sciences) version 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 66 patients with inguinal hernia were randomly divided into two groups (A and B)
| Arm | Type | Receives |
|---|---|---|
| Group-A: Laparoscopic hernia repair | Experimental | Procedure: HerniotomyIn group A (33 patients) laparoscopic assisted needle herniotomy was done |
| Group B open herniotomy | Active comparator | Procedure: HerniotomyIn group B(33 patients) open herniotomy was done |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients of age 6 months to 12 years of either gender having unilateral or bilateral inguinal hernia diagnosed on history, clinical examination and investigations.
Key exclusion criteria (5 listed)
- Patients with recurrent inguinal hernia, hydrocele, hernia with undescended testes and Sliding hernia diagnosed on history, clinical examination and investigations.
- Patients with complicated hernia (e.g. incarcerated ovary), irreducible or obstructed inguinal hernia diagnosed on history, clinical examination and investigations.
- Patients who cannot tolerate pneumoperitoneum or general anaesthesia.
- Patients with congenital heart disease, other co-morbid conditions.
- -
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: Laparoscopic herniotomyIn Group A Laparoscopic assisted needle herniotomy was done | Procedure or surgery | Group B open herniotomy, Group-A: Laparoscopic hernia repair |
Primary outcome
Operative time
Time frame: 3 months
Operative time was noted in both groups.
Recurrence
Time frame: 3 Month
recurrence was also noted in both groups
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 12 Apr 2024.
- Individual participant dataSharing planned: No. plan to share on demand
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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.
Muhammad Sharif study chair
King edward Medical University/Mayo Hospital Lahore
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 Inguinal Hernia, 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 5 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 12 Apr 2024. 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?
Operative time (time frame: 3 months). The study lists 2 primary outcomes in all. 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 12 Apr 2024.