| CTRI Number |
CTRI/2024/03/064021 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the outcome of groin swellings by open vs keyhole surgery in children. |
|
Scientific Title of Study
|
Outcome analysis of pediatric Inguinal hernia repair by Open versus Laparoscopic technique -An Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayush Bansal |
| Designation |
Junior Resident |
| Affiliation |
KLE Univeristy Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery, KLE Jawaharlal
Nehru Medical College
Belgaum
KARNATAKA
590010
India |
| Phone |
7760185520 |
| Fax |
|
| Email |
ayushbansal.p@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S.C Metgud |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery, KLE Jawaharlal
Nehru Medical College
Belgaum
KARNATAKA
590010
India |
| Phone |
9742502467 |
| Fax |
|
| Email |
drshrishailmetgud@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S.C Metgud |
| Designation |
Professor |
| Affiliation |
KLE University Jawaharlal Nehru Medical College |
| Address |
Department Of General Surgery, KLE Jawaharlal
Nehru Medical College
Belgaum
KARNATAKA
590010
India |
| Phone |
9742502467 |
| Fax |
|
| Email |
drshrishailmetgud@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of General Surgery, Jawaharlal Nehru Medical College,
Belagavi, Karnataka 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Ayush Bansal |
| Address |
Department Of General Surgery,
Jawaharlal Nehru Medical College, Belagavi
Karnataka 590010
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayush Bansal |
KLE’s Dr. Prabhakar Kore Hospital and Medical Research Centre |
Department Of General Surgery,
Jawaharlal Nehru Medical College Belagavi.
Belgaum
KARNATAKA |
07760185520
ayushbansal.p@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40||Inguinal hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. All children admitted in hospital for inguinal hernia repair.
2.Parents of the children willing to give consent |
|
| ExclusionCriteria |
| Details |
1.Children less than 1 year and more than twelve years are not included in the study.
2.Children with hernia other than inguinal hernia
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of operative time and post operative pain between open and laparoscopic repair of pediatric inguinal hernia. |
post operative pain would be assessed at the end of post operative day 0,1st. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of complications such as hematoma formation, erythema, hydrocele formation, scrotal edema & recurrence would be noted between the open & laparoscopic repair of pediatric inguinal hernia |
post operative day 3rd,7th & 1st month. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Herniotomy / open surgery has been the
time-honored treatment for pediatric inguinal hernia. The improvement of
pediatric Laparoscopic hernia and increased experience with Laparoscopic
technique became an important skill. Laparoscopic repair of inguinal hernias in
children is adopted too quickly, cost effective, cosmeticallybetter , less
invasive, more feasible and less painful. In our study we aimed
to compare between the outcomes and complications of the conventional opened
repair and the laparoscopic repair of pediatric inguinal hernia |