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CTRI Number  CTRI/2024/10/074854 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of post operative pain after mesh fixation with two different suture materials in patients operated for inguinal hernia repair. 
Scientific Title of Study   A randomised control trial of mesh fixation with polypropylene sutures (prolene) versus polyglactin sutures (vicryl) sutures in assessing inguinodynia in open inguinal hernia repair. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Shraddha Gajbhiye 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of General Surgery, Jawaharlal Nehru Medical College Sawangi (Meghe), Wardha
Sawangi Meghe Wardha Maharashtra- 442001
Wardha
MAHARASHTRA
442001
India 
Phone  7875372398  
Fax    
Email  gajbhiyeshraddha2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Imran Ali Khan 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7875372398  
Fax    
Email  drimk@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Imran Ali Khan 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of General Surgery Jawaharlal Nehru Medical College Sawangi (Meghe) Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  7875372398  
Fax    
Email  drimk@rediffmail.com  
 
Source of Monetary or Material Support  
Department of General Surgery Jawaharlal Nehru Medical College, Sawangi, Wardha-442001 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Department of General Surgery Jawaharlal Nehru Medical College Sawangi, Wardha- 442001 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Shraddha Gajbhiye  Department of General Surgery Jawaharlal Nehru Medical College Sawangi Meghe, Wardha Maharashtra- 442001 
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 Shraddha Gajbhiye  Jawaharlal Nehru Medical College  Department of General Surgery Jawaharlal Nehru Medical College Sawangi Meghe Wardha
Wardha
MAHARASHTRA 
7875372398

gajbhiyeshraddha2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Higher Education and Research (Deemed to be University)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dr. Shraddha Gajbhiye  To assess and compare post operative inguinodynia of prolene versus vicryl mesh fixation in open inguinal hernia repair 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Male 
Details  Inclusion Criteria:
1. Primary inguinal hernia
2. Uncomplicated hernia
3. Age range of 18 to 70 years
4. Unilateral or bilateral inguinal hernia
5. Nerve identification
 
 
ExclusionCriteria 
Details  Exclusion criteria
Irreducible hernias, patients with bleeding disorders, patients on anticoagulant treatment, pregnancy, patients needing emergency repair, HIV and HbsAg positive patients.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Based on the findings of the present study it may be concluded that, using polyglactin suture material to fix mesh is a safe, simple as well as an effective alternative to the conventional usage of polypropylene sutures for fixing the mesh in Lichtenstein hernia repair. The post- operative pain on day 1 and day 3 is similar with both vicryl and prolene sutures but on the day 7 and after 3 months it is significantly less.   Post operative day 1, 3, 7 and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Hence our study helps use to understand the benefits of using polyglactin sutures & also enables us to recommend its application to fix the mesh in Lichtenstien’s hernioplasty. So, routine usage of polyglactin (vicryl) sutures for mesh fixation in a Lichtenstien’s hernioplasty is safe & simple & thus a reasonable option.
 
Post operative day 1,3,7 & 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   11/10/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Inguinal hernia, the most frequently occurring type of hernia globally, Chronic groin pain could be related to nerve mangling while operating. Mesh repair can lead to an inflammatory reaction over a period of time, though it still needs ground work to find out exact cause of pain. So this study aims to compare the effectiveness of polyglactin versus prolene sutures in reducing the post-operative pain in inguinal hernia repair. Chronic pain in the groin is a notable problem post Lichtenstien’s repair, even though the pain is usually mild, studies have revealed that irrespective of the severity, chronic pain may considerably hamper day to day activity.  Chronic pain is the principle issue linked with the Lichtenstein technique with a conclusive rate between 15% and 40%. Routine usage of absorbable sutures to fix mesh in Lichtenstien’s repair have resulted in reduce post- operative chronic pain, yet controversies persist. So we took up this study to appraise post-operative groin pain in the patients where polyglactin sutures were used to fix the mesh (group A) versus polypropylene sutures in doing the same (group B) in Lichtenstein inguinal hernia repair. There have been many theories regarding the causes for the groin pain and one plausible theory is pain after surgery persists for a long period due to is inflammatory changes, fibrosis, subsequently entrapment of nerve, induced either by mesh or suture material, that’s in proximity of ilioinguinal nerve. Apart from this untimely mangling to nerve at the time of dissection may contribute as well to this. Vicryl (polyglactin) is a synthetic, absorbable, braided suture which can sustain its tensile strength for nearly 3 to 4 weeks in tissues. It’s entirely absorbed by hydrolysis within 60 days.

 
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