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CTRI Number  CTRI/2024/01/062167 [Registered on: 31/01/2024] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Inguinal Hernia Repair Techniques : Laparoscopic eTEP v/s Robotic rTAPP for operative duration and other outcomes  
Scientific Title of Study   Laparoscopic Extended Totally Extraperitoneal Repair (eTEP) versus Robotic Transabdominal Preperitoneal (Rtapp) Inguinal Hernia Repair: A 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 Mranal Karoliya 
Designation  JR General Surgery 
Affiliation  AIIMS Jodhpur 
Address  5B Block, 5th floor, OPD building, Department of General Surgery, AIIMS Jodhpur, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9928944884  
Fax    
Email  kmranal25@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramkaran Chaudhary 
Designation  Professor, Department of General Surgery AIIMS Jodhpur 
Affiliation  AIIMS Jodhpur 
Address  5B block, 5th floor OPD building, Department of General Surgery, AIIMS Jodhpur, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996892  
Fax    
Email  rkmoond@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ramkaran Chaudhary 
Designation  Professor, Department of General Surgery, AIIMS Jodhpur 
Affiliation  AIIMS Jodhpur 
Address  5B block, 5th floor OPD building, Department of General Surgery, AIIMS Jodhpur, Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8003996892  
Fax    
Email  rkmoond@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Jodhpur 
 
Primary Sponsor  
Name  Department of General Surgery AIIMS Jodhpur 
Address  5B block, 5th floor OPD building, Department of General Surgery, AIIMS Jodhpur, Jodhpur  
Type of Sponsor  Government medical college 
 
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 Mranal Karoliya  AIIMS Jodhpur  5B block, 5th floor OPD building, Department of General Surgery
Jodhpur
RAJASTHAN 
9928944884

kmranal25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Jodhpur Institutional Ethics Committee  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, (3) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (4) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laparoscopic eTEP  Patients aged over 18 years and undergoing Laparoscopic Enhanced Total Extra Peritoneal Repair for uncomplicated inguinal hernia 
Intervention  Robotic TAPP  Patients aged over 18 years undergoing robotic transabdominal preperitoneal repair for uncomplicated inguinal hernia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All consenting adult patients (18 years) with uncomplicated inguinal hernia coming to General Surgery OPD, AIIMS Jodhpur
 
 
ExclusionCriteria 
Details  Not consenting to participate in the study
Patient not fit to be operated under general anaesthesia
Recurrent hernia and strangulated hernia (complicated hernias)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Surgical Operative Time  Intraoperative 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain
Seroma
Hematoma
Post Op recurrence
Rate of conversion to Open
intraoperative Complication
Surgical site infection (SSI)
Post-operative length of hospital stay (in hours)
Incidence of postoperative urinary retention
Time (in days) to return to work
inferior epigastric artery injury
30 days complications
 
1 week, 4 weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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 3/ Phase 4 
Date of First Enrollment (India)   10/01/2025 
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="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 - NO
Brief Summary  

More than 20 million hernia repairs carried worldwide. With avident of modern technology hernia repair is shifting from laparoscopic to robotic techniques. We are trying to compare laparoscopic extended totally extraperitoneal repair (eTEP) versus robotic Transabdominal preperitoneal (rTAPP) inguinal hernia repair in terms of operative time , post operative pain and other variables. The Prospective observational study will be conducted in Department of General Surgery  at AIIMS, Jodhpur after obtaining the approval of institutional research committee and institutional ethics committee. Participants who meet the inclusion and exclusion criteria will be included in the study. Their demographics will be collected. On presentation after recruitment of the patient for study, complete history taking and general physical examination followed by routine investigation and special investigations will be done. Patient’s will be worked up for surgery as per institute protocol. When they undergo surgery, we will observe operative time, postoperative pain and various other factors. The patient will be monitored closely during there hospital stay for any postoperative complications, clavein dindo and modified clavein dindo score will be used. All the clinical parameters and the information obtained will be thoroughly assessed to fulfil the aim of the study and conclusion will be drawn.

P - Adult patient with unilateral inguinal hernia 

I - Robotic TAPP

C - Laparoscopic eTEP
O - Operative time
T - Not applicable


 
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