Comparison of Laparoscopic Herniotomy and Open Herniotomy... | NCT06356987

Studies
Comparison of Laparoscopic Herniotomy and Open Herniotomy in Children

NCT06356987

Sponsor

King Edward Medical University

Status

Completed

Last Update Posted

Apr 12, 2024Actual

Enrollment

66Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

Herniotomy

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Dec 31, 2021Actual

First Submitted Date

Mar 30, 2024

First Submission Date that Met QC Criteria

Apr 4, 2024

First Posted Date

Apr 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2024

Last Update Posted Date

Apr 12, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group-A: Laparoscopic hernia repair	Experimental	In group A (33 patients) laparoscopic assisted needle herniotomy was done	Procedure: Herniotomy
Group B open herniotomy	Active Comparator	In group B(33 patients) open herniotomy was done	Procedure: Herniotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Herniotomy	Procedure	In Group A Laparoscopic assisted needle herniotomy was done	Group B open herniotomy Group-A: Laparoscopic hernia repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Operative time	Operative time was noted in both groups.	3 months
Recurrence	recurrence was also noted in both groups	3 Month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Sharif	King edward Medical University/Mayo Hospital Lahore	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Muhammad Sharif		Lahore	Punjab Province	53711	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

plan to share on demand

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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