| CTRI Number |
CTRI/2024/07/071127 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study comparing the use of skin staples versus polypropylene sutures in Inguinal hernia repair for mesh fixation. |
|
Scientific Title of Study
|
Study comparing the use of skin staples versus polypropylene sutures in inguinal hernia repair for mesh fixation - a prospective randomised control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mridulika Verma |
| Designation |
Junior Resident, General Surgery |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Jawaharlal Nehru Medical College, Belagavi
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9528735124 |
| Fax |
|
| Email |
mridulikaverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anilkumar P. Bellad |
| Designation |
Professor |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
House number 147, Shree Basava Krupa, 1st Main, 3rd Cross Sadashivnagar, Belagavi
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE, Belagavi, Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9448112599 |
| Fax |
|
| Email |
anilbellad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mridulika Verma |
| Designation |
Junior Resident, General Surgery |
| Affiliation |
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE |
| Address |
Jawaharlal Nehru Medical College, Belagavi
KAHERs JAWAHARLAL NEHRU MEDICAL COLLEGE, Belagavi, Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9528735124 |
| Fax |
|
| Email |
mridulikaverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum-590010 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Mridulika Verma |
| Address |
Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum-590010 Karnataka, India |
| 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 Mridulika Verma |
Jawaharlal Nehru Medical College |
Department of General Surgery, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum-590010 Karnataka, India
Belgaum
KARNATAKA |
9528735124
mridulikaverma@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: N509||Disorder of male genital organs, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Polypropylene Sutures |
Mesh fixation done using conventional polypropylene sutures. The post operative pain is assessed 24 hours after the procedure. |
| Intervention |
Skin Staplers |
Mesh fixation done using skin staplers instead of regular polypropylene sutures. The post operative pain assessment is done 24 hours after the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
age between 18-60 years
sex :- both male and female ( non pregnant , non lactating )
non diabetic
patients willing to give informed consent |
|
| ExclusionCriteria |
| Details |
Complicated inguinal hernias
diabetes mellitus
chronic renal failure
immunocompromised patients
recurrent hernias
bleeding disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of post operative pain and operative time duration in Lichtenstein inguinal hernia repair when mesh is fixed using skin staplers. The post operative pain and operative duration is less when skin staplers are used to fix the mesh as compared to polypropylene sutures. |
Pain is assessed 24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of intraoperative time period |
1 hr |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Lichtenstein Inguinal hernia repair is a fairly common procedure with common postoperative complications like pain and surgical site infections. The study comparing the use of skin staples versus polypropylene sutures in inguinal hernia repair for mesh fixation demonstrates that there is reduction in pain and the operative time duration as compared to the conventional technique of mesh fixation with sutures. Reduced operative time also has shown to minimise the risk of wound infections . |