| CTRI Number |
CTRI/2024/07/070887 [Registered on: 19/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized study to compare two techniques( TEP and eTEP ) of groin hernia repair in terms of complications after surgery and surgeon learning duration |
|
Scientific Title of Study
|
Comparison of TEP vs eTEP technique for groin hernia repair in terms of post operative outcomes and learning curve : A Randomized 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 Asuri krishna |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.- 406, 4th floor, Surgery Blcok, All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
9999405767 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asuri krishna |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.- 406, 4th floor, Surgery Blcok, All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
9999405767 |
| Fax |
|
| Email |
dr.asurikrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D Lipton Mitra |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room No.- 406, 4th floor, Surgery Blcok, All India Institute of Medical Sciences, New Delhi.
South
DELHI
110029
India |
| Phone |
7827397680 |
| Fax |
|
| Email |
liptonmitra21@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, PIN code- 110029, India. |
|
|
Primary Sponsor
|
| Name |
Dr. Asuri Krishna |
| Address |
Room No.- 406,4th Floor, Surgery Block, All India Institute of Medical Sciences, New Delhi, Pin- 110029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Asuri Krishna |
All India Institute of Medical Sciences, New Delhi |
Room no- 406 4th floor
Surgery block All India Institute of Medical Sciences,
New delhi Pin-110029
South West
DELHI |
9999405767
dr.asurikrishna@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee AIIMS ot block Ansari Nagar New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
extended Total extraperitoneal repair |
The patient will be placed in a supine position with both hands by the side. The retro rectus space will be created after making a transverse incision just supero-lateral to the umbilicus in the contralateral para median region. The anterior rectus sheath will be incised to access the muscle fibers. The fibers will be split to expose the posterior rectus sheath, which will be used as a guide to enter the retro rectus space. A peanut dissector will be used for the dissection. The edges of the rectus sheath will be held using alley’s forceps. A Hasson’s cannula / 12mm port will be inserted and fixed using polyglactin suture. Space will be created in the retro rectus space using sharp and blunt dissection in caudal direction. Inferior epigastric vessels and Cooper’s ligament will be used as landmarks while doing dissection on the ipsilateral side. A 5 mm working port will be placed under vision just below the umbilicus. And a second 5 mm working port will be placed on the contralateral side just lateral and midway between umbilicus and pubic symphysis. Once encountered, the hernia sac will be identified and will be reduced. The vas deferens and gonadal vessels will be identified and preserved. Blunt dissection will proceed in the retrorectus space superomedially beyond the midline and inferomedially 2cm below the pubis in the space of Retzius. Once the space is created, an appropriate size plain heavyweight polypropylene mesh will be placed covering the space created. Proper hemostasis will be ensured. The retro rectus space will be desufflated under vision and ports will be removed. 12 mm ports will be closed using port polyglactin and the skin using 3’0 nylon suture.
In case of bilateral inguinal hernia, the retro rectus space will be created after making a transverse incision for 12mm port just supero-lateral to the umbilicus in the contralateral para median region. Two additional 5mm working ports will be inserted: one in suprapubic region and the other between this port and the umbilicus. Further dissection will be proceeded same as above on both sides. |
| Comparator Agent |
Total extraperitoneal repair |
The patient will be placed in a supine position with arms by the side. An infraumbilical vertical incision will be made 2cm below the umbilicus in the midline, and the incision will be deepened. The anterior rectus sheath will be incised, and the rectus abdominis muscle will be retracted. The retrorectus space will be created with peanut dissection, followed by placement of Hasson’s trocar. The retrorectus space will then be insufflated with CO2, and a telescope will be introduced for visualization.
Blunt dissection will be carried out in the retrorectus space with the telescope, and Coopers ligament will be identified. Two additional 5mm working ports will be inserted: one in suprapubic region and the other between this port and the umbilicus. Blunt dissection will proceed in the retrorectus space superomedially beyond the midline and inferomedially 2cm below the pubis in the space of Retzius. The hernial sac will be noted and divided if not reduced completely, and the vas deferens and gonadal vessels will be identified and preserved. Dissection will continue laterally until the anterior superior iliac spine (ASIS) is reached, and inferiorly where the vas deferens turns medially.
An adequate size polypropylene mesh will be placed and fixed medially with a tacker. Hemostasis will be achieved, and the abdomen will be desufflated. 12 mm ports will be closed using port polyglactin and the skin using 3’0 nylon suture.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients in the age group of 18-65 years with groin hernia |
|
| ExclusionCriteria |
| Details |
Complicated hernia (strangulated)
Patients unfit for general anesthesia
Patients who refused to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain, Wound infection, Seroma, Early Recurrence
|
At 6 hours, 24 hours, 1 week and 3months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the ease of operability, patient’s quality of life(WHOQOL-BREF), learning curve |
patient’s quality of life(WHOQOL-BREF) at the time of admission and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="0"
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
|
Inguinal hernia is one of the most common problems in surgical patients. Various approaches are available for inguinal hernia repair. In this study, we will include two techniques eTEP and TEP for inguinal hernia repair. TEP has been commonly used previously but it has been cumbersome due to poor ergonomics and small operating space. Beside this, larger size mesh can be placed. Our primary objective is to compare the postoperative outcome of eTEP and TEP repair for groin hernia in terms of complications - Post operative pain, Wound infection, Seroma and Early Recurrence. By exploring the data from this study, we aim to provide insights into potential difference in outcomes. Secondarily, the quality of life will be assessed pre operatively at the time of admission using Quality of life assessment proforma (WHO-QOL BREF) in Hindi/English. The same performa will be used 3 months post operatively in all domains of WHOQOL-BREF i.e., physical, psychological, social, environmental. Patients will be operated by two group of surgeons : Group 1 - Surgeon with extensive experience in laparoscopic groin hernia repair , Group 2 - Surgeon with extensive experience in basic and advanced laparoscopic surgery but inexperienced in groin hernia surgery. Considering the better ergonomics in eTEP technique and lesser postoperative complications with shorter learning curve, we propose this randomized trial to compare eTEP and TEP. |