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CTRI Number  CTRI/2025/02/080189 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
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   To analyse the effect of defect closure in laparoscopic inguinal hernia repair on post operative outcomes 
Scientific Title of Study   To analyse the effect of laparoscopic defect closure in direct inguinal hernia repairs (Total Extra-Peritoneal and Trans-Abdominal Pre-Peritoneal Plus repairs) on post operative outcomes 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ABIRAMI J RAGHUNATH 
Designation  GENERAL SURGERY RESIDENT 
Affiliation  Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research 
Address  No.1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600116
India 
Phone  9500013252  
Fax    
Email  abiraghu132@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr C D Narayanan 
Designation  Head of Department, Department of General Surgery 
Affiliation  Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research 
Address  No.1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600116
India 
Phone  9500013252  
Fax    
Email  cdnarayanan24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abirami J Raghunath 
Designation  General Surgery Resident 
Affiliation  Room 207, Second floor, G block, Department of General Surgery, Sri Ramachandra Institute of Higher Education and Research 
Address  No.1 Ramachandra Nagar, Porur, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600116
India 
Phone  9500013252  
Fax    
Email  abiraghu132@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 
 
Primary Sponsor  
Name  Abirami J Raghunath 
Address  No.1 Ramachandra Nagar, Porur Chennai, Tamil Nadu, India 600 116 
Type of Sponsor  Other [primary] 
 
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 Abirami J Raghunath  Sri Ramachandra Institute of Higher Education and Research  Room 207, 2nd floor, G block, Department of General Surgery, No.1 Ramachandra Nagar, Porur Chennai, Tamil Nadu, India 600 116
Chennai
TAMIL NADU 
9500013252

abiraghu132@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Ethics Committee (For PG Students of Medical College)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Closure of direct defect  In laparoscopic repair of inguinal hernia, the direct defect will be closed using absorbable barbed sutures. The duration of intervention would be for the time period of study, estimated for the next one year. 
Comparator Agent  Non closure of direct defect  The standard procedure for laparoscopic repair of inguinal hernia is done without closure of the defect. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients undergoing elective total extra-peritoneal and trans abdominal pre-peritoneal repairs for direct inguinal hernias
 
 
ExclusionCriteria 
Details  Patients undergoing emergency repair of hernia
Patients undergoing open repair
Patients undergoing hernia repair as part of another study
Patients with pre-existing infections or chronic infectious diseases such as tuberculosis
Patients not willing to participate in the study
Patients not willing for surgery
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Seroma formation assessed clinically and using USG when required
Recurrence of inguinal hernia assessed clinically
Post operative pain assessed using visual analog scale
 
Seroma formation upto 10 days post op
Recurrence of inguinal hernia upto 3 months post op
Post operative pain upto 3 months post op
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Operative time in minutes
2.Hernia defect size & EHS classification
3.Quality of life
 
1.Intraoperative
2.Pre-operative
3.Follow up of 3 months
 
 
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 4 
Date of First Enrollment (India)   21/02/2025 
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="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 - NO
Brief Summary  

Following totally extraperitoneal (TOTAL EXTRA-PERITONEAL REPAIRS) and transabdominal preperitoneal (TRANS ABDOMINAL PRE-PERITONEAL PLUS REPAIRS) repair, complications such as seroma formation, hernia recurrence, and postoperative pain have continued to present challenges to surgeons. Studies have demonstrated lower post-operative pain and shorter time to recovery associated with laparoscopic inguinal hernia repair when compared to open surgery. However, some studies have also described higher rates of seroma formation (up to 12%) and recurrence (up to 5%) with laparoscopic inguinal hernia repair, which      can result in decreased quality of life. In 2019, a study done in Singapore posited a modified laparoscopic technique involving primary closure of the direct hernia defect prior to mesh insertion in patients with direct inguinal hernia. They demonstrated a statistically significant reduction in recurrence and seroma formation, especially in certain at-risk patient populations, and proposed to name this procedure the “TOTAL EXTRA-PERITONEAL AND TRANS ABDOMINAL PRE-PERITONEAL PLUS” technique. Direct defect closure has proven to be effective in reducing recurrence and seroma formation post-operatively in patients undergoing laparoscopic inguinal hernia repair. The study stated that randomized controlled trials are required to further evaluate these outcomes. This is a prospective interventional parallel arm randomised controlled trial to be conducted at Sri Ramachandra Institute of Higher Education and Research. After obtaining consent, the patients will be assigned to case (closure of defect) and control (non-closure of defect) groups, using coin toss method. Closure of defect will be standardised with 2-0 VLOC barbed absorbable monofilament suture, and  psuedosac will be incorporated during defect closure. Incidence of postoperative complications namely post-operative pain, seroma formation and recurrence of hernia will be compared, with serial follow-up at 1 week, 1 month, and 3 months postoperatively.



 
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