| CTRI Number |
CTRI/2023/10/058656 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
use of Light weight mesh vs heavy weight mesh in open inguinal hernioplasty |
|
Scientific Title of Study
|
Light weight mesh vs Heavy weight mesh in open inguinal hernioplasty, a prospective and comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr C Nanda yashaswi |
| Designation |
Junior resident |
| Affiliation |
kasturba hospital MAHE |
| Address |
3rd floor Smt Sharada Madhav pai opd block department of General Surgery Kasturba hospital Manipal Udupi Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8886488698 |
| Fax |
|
| Email |
chittajallu.kmcmple2022@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil krishna M |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Hospital MAHE |
| Address |
3rd floor Smt Sharada Madhav pai opd block department of General Surgery Kasturba hospital Manipal Udupi Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986516627 |
| Fax |
|
| Email |
sunil.krishna@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil krishna M |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Hospital MAHE |
| Address |
3rd floor Smt Sharada Madhav pai opd block department of General Surgery Kasturba hospital Manipal Udupi Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9986516627 |
| Fax |
|
| Email |
sunil.krishna@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba hospital,Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital |
| Address |
3rd floor Sharada madhav pai OPD Department of General surgery Kasturba Hospital Manipal |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Nanda yashaswi |
Kasturba Hospital |
3rd floor sharada madhav pai OPD building, Department of General Surgery Kasturba Hospital Manipal
Udupi
KARNATAKA |
8886488698
chittajallu.kmcmple2022@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40-K46||Hernia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Inguinal Hernia who underwent Open Inguinal hernioplasty |
|
| ExclusionCriteria |
| Details |
1) Patients with recurrent Inguinal hernia repair 2) patients with previous surgeries in Inguinoscrotal region 3) patients who underwent Inguinal hernia repair without mesh 4) patient who underwent any other surgery concurrent with Inguinal Hernioplasty 5) Patients who want to get operated only in laparoscopic approach 6) All emergency Presentations 7) Patients less than 18yrs of age. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the Outcome of Light Weight mesh Vs Heavy Weight Mesh. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to Compare the PostOperative Pain, PostOperative Complications like Urinary Retention, Seroma Formation, Wound Infection, groin pain & Stiffness, Scrotal pain, To compare Chronic Inguinodynia, Inguinal stiffness, foreign body Sensation on followup & to compare recurrence on followup |
3months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
04/06/2024 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
There is a constant debate between usage of Light weight vs heavy weight mesh in Inguinal Hernia repair. More studies were done Concentrating on Laparoscopic repairs rather than Open repairs. Chronic pain rather than recurrence is considered as a Greater adverse Outcome.
Patient will be approached for participating in the study and will be explained the details regarding the same. An informed consent is taken once the patient agrees and then will be recruited into the study. He will be placed in either of two groups, namely Light weight mesh category or a Heavy weight mesh category which is entirely based upon the surgeon preference. After the procedure he will be monitored regarding factors like postoperative pain, infection seroma formation which will be mentioned in the outcome measuresPatients are followed up for Postoperative Complications like Infection, Seroma formation, Foreign body sensation, Groin Stiffness along with Recurrence and Chronic groin Pain. Pain Score Based on Visual analogue scale(VAS) recorded on a scale of 0 to 10 on Postoperative day 1, Postoperative day 2, 1st followup day, after 3months and after 6months. Patient data on Duration of Hospital stay and Duration to start Physical activity is noted. Patients are questioned on quality of life after surgery with a followup periodmof 6months |