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CTRI Number  CTRI/2019/12/022498 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 18/12/2019
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   Comparision of two different meshes in Hernia repair surgery 
Scientific Title of Study   Comparison of polypropylene versus polyester mesh in the Lichtenstein hernia repair with respect to chronic pain and inflammatory changes 
Trial Acronym  PROESTER 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajaypandian 
Designation  MS General Surgery (First year resident)  
Affiliation  PIMS 
Address  MS General Surgery (First year resident) PIMS, Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  8825520836  
Fax    
Email  srimugilmecse@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sampath Kumar 
Designation  Professor  
Affiliation  PIMS 
Address  Professor Department of General Surgery, Pondicherry Institute of medical sciences,Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  9486267863  
Fax    
Email  skdrsampathkumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ajaypandian 
Designation  MS General Surgery (First year Resident) 
Affiliation  PIMS 
Address  First year resident, MS General Surgery, Pondicherry Institute of medical sciences.Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  8825520836  
Fax    
Email  srimugilmecse@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of medical sciences, kalathumettupathai, Ganapathichettikulam, Village no 20, kalapet, puducherry, 605014 
 
Primary Sponsor  
Name  Dr Ajaypandian 
Address  Junior resident Department of General Surgery Pondicherry Institute Of Medical Sciences Puducherry 
Type of Sponsor  Other [Dr Ajaypandian] 
 
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 Ajaypandian  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES  Address : Kalathumettupathai, Ganapathichettikulam, Village No.20, Kalapet, Puducherry, 605014 Pondicherry PONDICHERRY
Pondicherry
PONDICHERRY 
8825520836

srimugilmecse@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTEE(IEC), Registered with CDSCO- Reg No ECR/400/Inst/Py/2013, Pondicherry Institute Of Medical Sciences, Kalapet, Puducherry - 605014  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polyester mesh  To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polyester mesh 
Comparator Agent  To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polypropylene mesh  To assess the postoperative pain following Lichtenstein inguinal hernioplasty using polypropylene mesh 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients of age above 18 years with unilateral inguinal hernia presenting to PIMS undergoing surgery, willing to participate in this study 
 
ExclusionCriteria 
Details  1.Patients with strangulated hernia,
2.Recurrent hernia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the postoperative pain following Lichtenstein inguinal hernioplasty using polyester vs. polypropylene mesh  Post operatively after 1 week and after 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assessment of inflammatory markers like [hsCRP, IL 6] in pre-op and postop at 12 hours
2.To document the duration of operative time, duration of hospital stay.
3.Assessment of surgical site infections, seroma and hematoma formation 
Post operative assessment 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   30/12/2019 
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)?  

Brief Summary   Inguinal hernias are the most common operative procedures performed by general surgeons. Various procedures described to improve outcome in terms of decrease chronic pain and recurrence. Lichtenstein hernia repair showed a significant reduction in recurrence and also chronic pain. Usage of lightweight mesh materials like polyester is found to reduce inguinal hernia pain as compared to polypropylene mesh and improve quality of life. Prosthetic materials induce an inflammatory response characterized by an increased level of IL-6 and hsCRP.
Chronic pain is that pain which persists at the surgical site and nearby surrounding tissues 3 months after surgery. Despite adequate research chronic postoperative pain continues to be a significant problem in hernioplasty. Polyester mesh has a higher degree of connective tissue integration, it has less mesh contraction, less fibrous encapsulation and less stiffness around the mesh. Prosthetic materials induce an inflammatory response characterized by an increased level of IL-6 and hsCRP, however, there is no significant difference between preoperative
level, 12 hr, 48hr, and 2weeks. The main reasons hypothesized for chronic groin pain are per-operative nerve damage, post-operative fibrosis, or mesh-related fibrosis. They have been classified as either neuropathic or non-neuropathic pain. The three nerves potentially involved are the Ilioinguinal Nerve (IIN), Iliohypogastric Nerve (IHN) and genital branch of the Genitofemoral Nerve (GFN). These nerves can be damaged either by trauma during dissection or retraction of tissues, or nerve entrapment from post-operative fibrosis, mesh-related fibrosis or sutures used to fix the mesh. Non-neuropathic causes are excessive scar formation resulting from prosthetic mesh reaction, the periosteal reaction from sutures or staples inserted into the pubic tubercle or due to rolled-up bulky mesh leading to mechanical pressure. Hereby we are conducting a study to compare the efficacy between polypropylene mesh and polyester mesh in terms of pain, inflammatory changes
 
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