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CTRI Number  CTRI/2026/02/105068 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare two minimally invasive techniques for groin hernia repair 
Scientific Title of Study   Outcomes of TEP Repair by Conventional vs 555 Manish Technique for Groin Hernia Repair - Randomized Control 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 Abha Chugh 
Designation  Third year general surgery resident 
Affiliation  Sir Ganga Ram Hospital 
Address  Room number 1317 Department of Laparoscopic Laser and General Surgery Sir Ganga Ram Hospital Rajinder Nagar New Delhi 110060 India

New Delhi
DELHI
110060
India 
Phone  8668586890  
Fax    
Email  abhachugh1617@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manish Gupta 
Designation  Senior Consultant and Vice Chairperson 
Affiliation  Sir Ganga Ram Hospital 
Address  Room number 1317 Department of Laparoscopic Laser and General Surgery Sir Ganga Ram Hospital Rajinder Nagar New Delhi 110060 India

New Delhi
DELHI
110060
India 
Phone  9811671157  
Fax    
Email  drmanishgupta2002@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Abha Chugh 
Designation  Third year general surgery resident 
Affiliation  Sir Ganga Ram Hospital 
Address  Room number 1317 Department of Laparoscopic Laser and General Surgery Sir Ganga Ram Hospital Rajinder Nagar New Delhi 110060 India

New Delhi
DELHI
110060
India 
Phone  8668586890  
Fax    
Email  abhachugh1617@gmail.com  
 
Source of Monetary or Material Support  
Institutional academic study conducted at Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, 110060, India. No external funding. 
 
Primary Sponsor  
Name  Dr Abha Chugh 
Address  Department of General Surgery Sir Ganga Ram Hospital Rajinder Nagar New Delhi 110060 India 
Type of Sponsor  Private hospital/clinic 
 
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 Abha Chugh  Room Number 1317, Department of Laser, Laparoscopic and General Surgery, Sir Ganga Ram Hospital  Rajinder Nagar New Delhi 110060 India
Central
DELHI 		 8668586890

abhachugh1617@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  555 Manish technique for Total Extraperitoneal repair  555 Manish technique for Total Extraperitoneal repair using three 5 mm ports with optical entry into pre peritoneal space 
Comparator Agent  Conventional TEP repair  Conventional TEP repair using infraumbilical 12 mm Hasson trocar with two 5 mm working ports and closure of anterior rectus sheath afterwards. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with groin hernia who are fit for TEP repair 
 
ExclusionCriteria 
Details  Patients not willing to consent to take part in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Post-operative pain at the infraumbilical port site using VAS score   12 hours, 24 hours, day 7 and 30 after the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative time taken in seconds from point of incision to reaching upto Preperitoneal space  Incision to entering Preperitoneal space 
Post-operative infraumbilical port site induration in millimetres using a plastic scale   Day 7 after surgery 
Post-operative cosmetic outcome and patient satisfaction using VAS score   Day 30 of surgery 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2026 
Date of Study Completion (India) 05/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="20" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This randomised controlled trial aims to compare perioperative and short-term postoperative outcomes between conventional TEP repair and the 555 Manish technique for groin hernia repair. A total of 70 patients with groin hernia undergoing TEP repair were randomised into two groups (35 per arm). The primary outcome measure is postoperative infraumbilical port-site pain assessed using the Visual Analogue Scale (VAS) at 12 hours, 24 hours, day 7, and day 30. Secondary outcomes include time taken to reach the pre-peritoneal space, infraumbilical port-site induration at day 7, and cosmetic outcome and patient satisfaction at day 30. The study evaluates whether the 555 Manish technique provides early recovery and patient-centred outcomes compared to conventional TEP repair.

 
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