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CTRI Number  CTRI/2023/09/057520 [Registered on: 12/09/2023] Trial Registered Prospectively
Last Modified On: 10/09/2023
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   A Comparative Study of early post operative complications after Two Different Type of laparoscopic Hernia Surgery i.e., Laparoscopic enhanced view Totally Extra Peritoneal (eTEP) And Trans Abdominal Pre-Peritoneal (TAPP) Repair  
Scientific Title of Study   A randomised control study to compare Extended view Totally Extraperitoneal Repair (eTEP) vs Trans Abdominal Pre-Peritoneal Repair (TAPP) in terms of early post-operative complications in groin hernias 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Srishti Bishnoi 
Designation  PG student 
Affiliation  ABVIMS, Dr. RML Hospital 
Address  Department of General Surgery ABVIMS, Dr. RML hospital New Delhi 11001 India

Central
DELHI
11001
India 
Phone  7015174902  
Fax    
Email  bishnoisrishti@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeti Kapur  
Designation  Professor 
Affiliation  ABVIMS and Dr. RML Hospital, New Delhi 
Address  Department of General Surgery ABVIMS, Dr. RML hospital New Delhi 110001 India

Central
DELHI
110001
India 
Phone  9818182212  
Fax    
Email  neetikapur2004@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Srishti Bishnoi 
Designation  PG student 
Affiliation  ABVIMS, Dr. RML Hospital 
Address  Department of General Surgery ABVIMS, Dr. RML hospital New Delhi 11001 India

Central
DELHI
11001
India 
Phone  7015174902  
Fax    
Email  bishnoisrishti@gmail.com  
 
Source of Monetary or Material Support  
Department of Surgery, ABVIMS and Dr. RML Hospital, New Delhi 110001 
 
Primary Sponsor  
Name  ABVIMS, Dr. RML hospital 
Address  Department of General surgery, ABVIMS, Dr. RML hospital 
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 Srishti Bishnoi  ABVIMS , Dr RML Hospital  Department of general surgery, ABVIMS, Dr RML Hospital, New Delhi, 11001
Central
DELHI 
7015174902

bishnoisrishti@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ABVIMS, Dr. RML Hospital, New Delhi  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  Enhanced view Totally Extraperitoneal Repair (eTEP)  eTEP will be used for the repair of primary inguinal hernia in a time period of 1 year 2 months 
Comparator Agent  Trans-Abdominal Pre-Peritoneal Repair (TAPP)  TAPP will be used for the repair of primary inguinal hernia in a time period of 1 year 2 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Consecutive Adult patients with primary inguinal hernia 
 
ExclusionCriteria 
Details  Previous lower abdominal surgeries
Recurrent hernia
Obstructed or strangulated hernia
Associated hydrocele, epididymitis
H/O orchidectomy
ASA 3 or more 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early post-operative complications
pain
seroma
scrotal hematoma 
1 hour, 6 hours, 24 hours, 7 day, 30 day, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Intra-op complications
Operative Time
Length of hospital stay 
3 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   07/12/2023 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Groin hernia is one of the commonest problems encountered in general surgery practice.

Surgical procedure is the mainstay of management of groin hernia. Groin hernias can be repaired by either open or laparoscopic techniques. With advancements in endoscopic technology, laparoscopic hernia surgery is being increasingly used.

Earlier, open hernia repair used to be the most common form of hernia repair. However, recently minimally invasive surgery has become a more popular procedure for surgeons. It utilizes posterior approach for repair of hernias in contrast to the anterior approach seen in open hernia repair.

Understanding the anatomy of the posterior approach is imperative in performing a successful dissection. Considering this, Daes and Felix introduced the concept of critical view of Myopectineal Orifice. The anatomy of myopectineal orifice is defined as follows; it is bounded medially by the rectus abdominis muscle, laterally by the psoas, inferiorly by the pectineus ligament and superiorly by transversus abdominis muscle along with internal oblique muscle.

The Extended view total extraperitoneal approach (eTEP) offers the advantage of reduced risk of intestinal and vascular injuries as the peritoneum is not breached and  abdominal cavity is not entered. It allows for easy and fast creation of extraperitoneal space along with a wider surgical field and improved tolerance for pneumoperitoneum. It also allows for the laparoscopic repair in cases of obese patients, short umbilicus to pubic tubercle distance and in previous pelvic surgeries.

Transabdominal pre-peritoneal hernia repair (TAPP) offers the advantage of having a shorter learning curve, being able to diagnose occult hernias and in the repair of incarcerated or strangulated hernias.

This study aims at comparing Extended view Totally extra-peritoneal repair (eTEP) and Trans abdominal pre peritoneal repair (TAPP) and whether these are comparable in terms of early post-operative complications as no such study on eTEP and TAPP has been published.

 
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