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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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 
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