| CTRI Number |
CTRI/2023/06/054038 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study for analysis of risk factors of Surgical Site Infection in Hernia Mesh plasty patients. |
|
Scientific Title of Study
|
A Prospective Study for analysis of Incidence of Surgical Site Infection in Hernia Meshplasty patients & To Study Risk Factors causing Surgical Site Infection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naveenkumar G |
| Designation |
Junior Resident Doctor |
| Affiliation |
Bhabha Atomic Research Centre |
| Address |
Room no 31,RMO Men quarters , 5 th floor
Bhabha atomic research centre and hospital, Anushakthinagar, mumbai 400094 Room no 2,surgical OPD, Department of General surgery, First floor
Bhabha atomic research centre and hospital,
Anushakthinagar,
mumbai 400094. Mumbai MAHARASHTRA 400094 India |
| Phone |
9047796209 |
| Fax |
|
| Email |
nawinvinayak2.0@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Jayesh kalbhande |
| Designation |
SURGICAL CONSULTANT |
| Affiliation |
Bhabha Atomic Research Centre |
| Address |
Consultant
Surgical unit
DEPARTMENT OF SURGERY
BHABHA ATOMIC RESEARCH CENTER AND HOSPITAL
ANUSHAKTHINAGAR
MUMBAI
400094 Consultant
Surgical unit
DEPARTMENT OF SURGERY
BHABHA ATOMIC RESEARCH CENTER AND HOSPITAL
ANUSHAKTHINAGAR
MUMBAI
400094 Mumbai MAHARASHTRA 400094 India |
| Phone |
9047796209 |
| Fax |
|
| Email |
jayeshkalbhande@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Naveenkumar G |
| Designation |
Junior Resident Doctor |
| Affiliation |
Bhabha Atomic Research Centre |
| Address |
Room no 31,RMO quarters , 5 th floor
Bhabha atomic research centre and hospital, Anushakthinagar, mumbai 400094 Room no 2,Surgical OPD, Department of General surgery, 1 st floor
Bhabha atomic research centre and hospital,
Anushakthinagar,
mumbai 400094. Mumbai MAHARASHTRA 400094 India |
| Phone |
9047796209 |
| Fax |
|
| Email |
nawinvinayak2.0@gmail.com |
|
|
Source of Monetary or Material Support
|
| HEAD OF MEDICAL DIVISION
DIVISIONAL ADMINISTRATIVE OFFICE
BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL
ANUSHAKTHINAGAR
MUMBAI
400094 |
|
|
Primary Sponsor
|
| Name |
BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL |
| Address |
HEAD OF MEDICAL DIVISION
BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL
ANUSHAKTHI NAGAR
MUMBAI
400094 |
| Type of Sponsor |
Other [CENTRAL GOVERNMENT HOSPITAL] |
|
|
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 NAVEENKUMAR G |
BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL |
DEPARTMENT OF GENERAL SURGERY
FIRST FLOOR, MEDICAL DIVISION
BHABHA ATOMIC RESEARCH CENTRE AND HOSPITAL
ANUSHAKTHI NAGAR
MUMBAI 400085 Mumbai MAHARASHTRA |
9047796209
nawinvinayak2.0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics committee ,Bhabha atomic research centre and hospitall |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
whom above 18 years of age, undergoing Polypropylene mesh repair for hernia |
|
| ExclusionCriteria |
| Details |
1. Failure of consent
2. Patients having ascites
3. Patients on immunosuppressant
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of surgical site infection |
90 days post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean hospitalization time
2.Readmission in hospital
|
90 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="125" Sample Size from India="125"
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)
|
23/06/2023 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Treatment of Hernia has got modified last few decades. Initially locally available tissue were used for hernia surgery. It was then called as Herniorrhaphy. Later on Mesh were introduced for treatment of hernia surgery. Use of mesh revolutionized the management of hernia surgery. Mesh reduced the chances of recurrence of hernia as compared to tissue based repair. Use of Mesh during surgery is labelled as Mesh Hernioplasty surgery. And Mesh hernioplasty has become standard of care procedure for treatment of all hernia cases. Therefore, Mesh hernioplasty is the most common surgery performed for all types of hernia. Polypropylene mesh is one of the most versatile mesh to be used during surgery. It is resistant to infection. It can withstand mild infection and it can be preserved in our body in spite of getting infection. Therefore, it is the preferred mesh used in all types of hernia surgery. Use of any synthetic prosthesis implantation in our body is invariably associated with risk of developing a prosthetic infection. However, chances of infection associated with polypropylene mesh hernioplasty is very low. Traditionally it is described in literature as approximately 5%. Such infection may manifest in the form of fever, myalgia, erythema of overlying skin and in some cases as chronic discharging sinus. Development of infection may leads to increased morbidity. Occasionally there may be a need of removal of mesh to cure the infection. This study envisages to check rate of surgical site infections in patients operated for hernia meshplasty surgery and to look forrisk factors for infections in patients operated for mesh hernioplasty. Primary objective being analysis of incidence of surgical site infection (SSI) in patients operated for hernia meshplasty. Secondary objective being to assess risk factors for surgical site infection in cases operated for hernia meshplasty |