| 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
|
|
|
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
|
|
|
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. |