| 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
|
|
|
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 |
|
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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 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
|
|
|
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)
|
|
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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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