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CTRI Number  CTRI/2025/12/099975 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 29/12/2025
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   3D mesh comparison with normal flat mesh in inguinal hernia repair 
Scientific Title of Study   Surgical outcomes of 3-Dimensional mesh compared with polypropylene mesh in laparoscopic inguinal hernia repair : A randomized trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shreya Gupta 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9812161230  
Fax    
Email  9.216.shreya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhupendra Mehra 
Designation  Professor  
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Room no 206, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9822817958  
Fax    
Email  drbhupi_mehra@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shreya Gupta 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Room no 202, OPD building, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur

Nagpur
MAHARASHTRA
441108
India 
Phone  9812161230  
Fax    
Email  9.216.shreya@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 
 
Primary Sponsor  
Name  Dr Shreya Gupta 
Address  Room no 202, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur Nagpur, 441108 MAHARASHTRA 
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 
Dr Shreya Gupta  All India Institute of Medical Sciences  Room no 202, Department of General Surgery, All India Institute of Medical Sciences, Mihan, Dahegaon, Nagpur 441108
Nagpur
MAHARASHTRA 		 9812161230

9.216.shreya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Department of Pharmacology, AIIMS Nagpur  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  Placement of 3-Dimensional Mesh in laparoscopic inguinal hernia repair  One group will be intervened by placement of 3-Dimensional mesh in laparoscopic inguinal hernia repair. The primary advantage of 3D pre-shaped meshes is twofold: first, it reduces operative time. Second, they do not require fixation, they are associated with a lower risk of nerve injury and chronic pain which may occur during tacking or suturing. Therefore, theoretically, postoperative pain should be lower. 
Comparator Agent  Placement of Flat polypropylene mesh in laparoscopic inguinal hernia repair  Second group will be intervened by placement of Polypropylene meshes in laparoscopic inguinal hernia repair. However, they are sometimes associated with complications such as chronic postoperative pain, infection, and mesh shrinkage. These issues are usually associated with the physical properties of the mesh as well as the patient’s inflammatory response. To mitigate these side effects, recent meshes are designed with larger pores and are relatively lightweight. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients with Unilateral or Bilateral Inguinal Hernia , gender- male and female with Age- 18-75 years 
 
ExclusionCriteria 
Details  Patients with Recurrent inguinal hernia , Obstructed hernia, Strangulated hernia, Irreducible Inguinal hernia
Patients below 18years age
Patients with Psychiatric illness
Patients with Previous midline scars
Patients with Immunocomprised status or uncontrolled diabetes or any major comorbidities
Patients with Inability to complete follow up protocol
Patients with conversion of lap to open hernia repair
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the intra-operative and post-operative complications between 3D mesh and Polypropylene mesh among patients with clinically or radiologically proven Inguinal Hernia admitted undergoing laparoscopic inguinal hernia repair .   Patients will be followed up on post-operative days 1 and 3 for pain and seroma formation. Dressing will be changed on post-operative day 3 to assess wound infection. Skin sutures will be removed on post-operative day 10.
Follow-up protocol after suture removal: 1 Month, 3 Months, and 6 Months: QOL and Recurrence. 
 
Secondary Outcome  
Outcome  TimePoints 
Total operating time
Post-operative pain
Use of additional analgesia
Return to work
Wound complications (seroma & wound infection)
Recurrence
Quality Of Life (QOL) Parameters
Hospital stay
treatment cost  		 Total operating time
Day-3, 1 month, 3 months, 6 months
Use of additional analgesia - yes/no
Return to work
Wound complications (seroma & wound infection)
Recurrence
1 month, 3 months, 6 months, 12 months
Total Hospital stay
Total treatment cost  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   12/01/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included 9.216.shreya@gmail.com).

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Inguinal hernia is the most common abdominal wall hernia, with a significantly higher incidence in males. Its development is influenced by congenital factors, posterior wall weakness, and conditions that raise intra-abdominal pressure. While open mesh repair has been the traditional standard, laparoscopic approaches such as Transabdominal Preperitoneal and Totally Extraperitoneal repair are increasingly preferred for their reduced postoperative pain, quicker recovery, and shorter hospital stay. Polypropylene mesh remains widely used but is associated with chronic pain, seroma formation, and mesh shrinkage. Newer three-dimensional anatomically contoured meshes have been introduced to improve conformity to the preperitoneal space, reduce the need for fixation, and potentially lower postoperative discomfort and complications. This study aims to compare surgical outcomes of three-dimensional mesh with polypropylene mesh in laparoscopic inguinal hernia repair at a tertiary care center in central India. 
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