| CTRI Number |
CTRI/2024/07/071609 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the results of two surgical techniques (Midline Vs Triangular Port) used to repair groin hernia via key hole extra-peritoneum approach |
|
Scientific Title of Study
|
Midline Vs Triangular Port Placement in Total Extra‑Peritoneal Mesh Repair in Uncomplicated Inguinal Hernia: 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 |
Manjunath Maruti Pol |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, fourth floor, 416, Surgery Block, AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
9990187137 |
| Fax |
|
| Email |
manjunath.pol@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Ranjan Kumar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, Surgery Unit-2, B-1 ward, Surgery Block, AIIMS, Ansari Nagar, New Delhi
South
DELHI
110029
India |
| Phone |
8178926876 |
| Fax |
|
| Email |
rvranjan1102@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Ranjan Kumar |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences New Delhi |
| Address |
Department of Surgical Disciplines, first floor, Surgery Unit-2, B-1 ward, Surgery Block, AIIMS, Ansari Nagar, New Delhi
DELHI
110029
India |
| Phone |
8178926876 |
| Fax |
|
| Email |
rvranjan1102@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences Ansari
Nagar New Delhi South DELHI |
| 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 |
| Manjunath Maruti Pol |
AIIMS Delhi |
Department of Surgical Disciplines, Surgery Block, All India Institute of Medical Sciences Ansari Nagar New Delhi
South
DELHI |
9990187137
manjunath.pol@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Midline port TEP repair |
The three ports are placed in a linear fashion |
| Intervention |
Triangular port TEP repair |
The three ports are placed in a triangular fashion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Consenting to participate in the study and follow-up |
|
| ExclusionCriteria |
| Details |
1. Less than 18 years and more than 80 years of age
2. Complicated inguinal hernia (Obstructed, Strangulated, Prior inguinal hernia surgery, Previous lower abdomen surgery)
3. Bilateral Inguinal Hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare ergonomic suitability for the surgeon between midline versus triangular port placement in Total Extra‑Peritoneal Mesh Repair (Body part discomfort questionnaire by SAGES and Surgeon satisfaction score)
2. To compare energy expenditure of the operating surgeon during the surgery (Using Apple Health App on Apple watch SE2).
|
1. 2 hours
2. 2 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Postoperative pain using VAS score
2. Intraoperative complications (cord injury, vascular injury, or visceral organ injury)
3. postoperative complications [using the Clavien-Dindo Score]
4. length of hospital stay
5. Time taken to unfurl the mesh (from insertion to mesh fixation).
|
1. at 12 hours, 24 hours, 7 days and 30 days
2. 2 hours
3. 30 days
4. 7 days
5. 2 hours |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Justification for the study:
·
TEP (total extra‑peritoneal mesh repair) and
TAPP (Trans-abdominal pre-peritoneal mesh repair) are two commonly used
laparoscopic surgical techniques for inguinal hernia repair
·
In TEP it doesn’t require to enter inside the
abdominal cavity so the risk of visceral injury, port site hernia and
post-operative adhesions are low. However, it has certain limitations like
narrow working space, low angle of manipulation, difficulty in unfurling of
mesh, crowding of instruments (especially in short stature patients) so surgeons
have been trying to find different port positions to deal with these
difficulties.
·
Singh S. et al. (Surg Endosc, 2021) did RCT and
compared two different techniques for TEP and concluded that triangular port
placement is ergonomically better than midline port placement, However the
primary outcome in the study was postoperative pain and not ergonomics.
·
Xiaoqiang Zhu et.al (Journal of surgical
research 2019) in and RCT found that triangular port placement has advantages
like better triangulation of instruments, ease in sac dissection, ease in
suturing if required
·
A RCT with a good design, a sufficient sample
size, is required to settle the debate over the ergonomically better technique
for TEP repair. Hence, there is a need to conduct this study.
The purpose of this study is to investigate the
ergonomics of triangular vs. midline port placement in TEP repair. |