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CTRI Number  CTRI/2022/02/040413 [Registered on: 18/02/2022] Trial Registered Prospectively
Last Modified On: 17/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized Factorial Trial 
Public Title of Study   Comparison between two mesh groups in open inguinal hernia repair 
Scientific Title of Study   Comparative study of polypropylene mesh versus polyester mesh in open inguinal hernia repair  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrTharun Ganapathy 
Designation  associate professor  
Affiliation  Srm Medical College Hospital and Research Centre 
Address  SRM Medical College Hospital and Research Centre kattankulathur
Department of general surgery kattankulathur
Kancheepuram
TAMIL NADU
603203
India 
Phone  9840044437  
Fax    
Email  drtarunchitrambalam@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrTharun Ganapathy 
Designation  associate professor  
Affiliation  Srm Medical College Hospital and Research Centre 
Address  SRM Medical College Hospital and Research Centre kattankulathur
Department of general surgery kattankulathur
Kancheepuram
TAMIL NADU
603203
India 
Phone  9840044437  
Fax    
Email  drtarunchitrambalam@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrTharun Ganapathy 
Designation  associate professor  
Affiliation  Srm Medical College Hospital and Research Centre 
Address  SRM Medical College Hospital and Research Centre kattankulathur
Department of general surgery kattankulathur
Kancheepuram
TAMIL NADU
603203
India 
Phone  9840044437  
Fax    
Email  drtarunchitrambalam@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical college hospital and research centre  
 
Primary Sponsor  
Name  Dr Sundeep  
Address  4/26 bharathi street west mambalam chennai 600033 
Type of Sponsor  Other [self] 
 
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 
sundeep  SRM Medical College hospital and research centre  Department of general surgery Room number 300 Third floor B block kattankulathur
Kancheepuram
TAMIL NADU 
9790756554

sundeep.kumaran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research centre Institutional Ethical committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  lichtenstein tension free repair   Open inguinal hernioplasty- with placement of either one of two meshes studied after reducing the hernial contents and posterior all plication if applicable  
Comparator Agent  nil applicable   nil applicable  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of both sexes aged more than 18 years of age and giving valid written informed consent.
Patient with unilateral or bilateral inguinal hernia
 
 
ExclusionCriteria 
Details  Complicated hernia
Co-morbidities
Recurrent inguinal hernia
COPD/BPH or any other associated illness causing increased intra-abdominal pressure
Patients not willing for the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To assess the post operative pain between polypropylene mesh and polyester mesh  Post operative pain is assessed 24 hours, 48 hours, 3 days, 7 days, 2 weeks, 4 weeks , 3 months using visual analogue scale  
 
Secondary Outcome  
Outcome  TimePoints 
to assess the complication rate among both mesh group like seroma, infection   to assess the complication rate among both mesh group like seroma, infection at 24 hours, 48 hours, 1 week, 3 weeks, 3 months 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/02/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

ABSTRACT

BACKGROUND:

Inguinal hernia is one of the most common surgical problems presenting to the surgical out patient department. Surgery being main treatment for hernia, surgical techniques of inguinal hernia has undergone a great development over a period of centuries and decades. Litchenstein’s tension free hernia repair have revolutionized the procedure and is the one of the first surgeries learnt by a surgery resident. Although the recurrence rates in hernia surgery have drastically been brought down by the placement of mesh, post operative pain still remain troublesome in hernia repair. Polyester is an softer pliable material offering the benefit of less post operative pain and improved quality of life than the routinely used polypropylene mesh

 

METHODS:

A prospective single blinded randomized control trial involving 144 patients who underwent Lichtenstein tension free repair were divided equally in 2 groups Group A - polypropylene mesh(n=72) and Group B polyester mesh (n=72). All the patients were operated by a single surgeon to maintain uniformity. Postoperatively, pain was assessed and compared using Visual Analogue Score (VAS) at 12 hours, 24 hours and 48 hours in the hospital and at 1 week, 1 month, and 3 months on outpatient basis. Additional analgesic requirements were recorded and postoperative complications were noted and compared.

CONCLUSION:

The usage of polyester mesh in open inguinal hernia repair was comparable and superior with that of polypropylene mesh in terms of less early and intermediate post operative pain, decreased additional analgesic requirements and reduced duration of stay in the hospital.

 

 
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