| CTRI Number |
CTRI/2019/05/018935 [Registered on: 03/05/2019] Trial Registered Prospectively |
| Last Modified On: |
02/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective study of eTEP a new technique of hernia repair in cases of hernioplasty for ventral hernia |
|
Scientific Title of Study
|
A PROSPECTIVE STUDY OF EXTENDED-VIEW TOTALLY EXTRAPERITONEAL (e-TEP) TECHNIQUE IN INGUINAL, VENTRAL AND UMBILICAL HERNIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jignesh Joshi |
| Designation |
PG STUDENT |
| Affiliation |
government medical college bhavnagar |
| Address |
Department of General Surgery,government medical college bhavnagar
Department of General Surgery,government medical college bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8980997706 |
| Fax |
|
| Email |
joshijignesh45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Firdaus A Dekhaiya |
| Designation |
Associate Professor and Head of Unit, Department of General Surgery |
| Affiliation |
government medical college bhavnagar |
| Address |
Department of General Surgery,government medical college bhavnagar
Department of General Surgery,government medical college bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825133976 |
| Fax |
|
| Email |
drfirdausd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Firdaus A Dekhaiya |
| Designation |
Associate Professor and Head of Unit, Department of General Surgery |
| Affiliation |
government medical college bhavnagar |
| Address |
Department of General Surgery,government medical college bhavnagar
Department of General Surgery,government medical college bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9825133976 |
| Fax |
|
| Email |
drfirdausd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college, Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government Medical college Bhavnagar |
| Address |
sir t hospital bhavnagar,government medical college bhavnagar |
| 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 Jignesh Joshi |
Sir T hospital bhavnagar |
Department of General Surgery,government medical college, Jail road, bhavnagar
Bhavnagar
GUJARAT |
8980997706
joshijignesh45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, (2) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, (3) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Operative method: eTEP (extended TEP) method. |
It is a novice laparoscopic method of correcting inguinal and umbilical hernias and ventral hernias. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients with inguinal, umbilical and ventral hernias, new or recurrant
(2) Age between 15 to 65 years
(3) Patients fit for laparoscopic surgery
|
|
| ExclusionCriteria |
| Details |
1) Patients not fit for laparoscopic surgery
(2) Those who are unwilling for e-TEP
(3) Patients having medical comorbidities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to reach to a conclusion of overall efficacy and feasibility of e-TEP in various types of hernia repairs.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in morbidity post op, reduction in post op pain and reduced hospital stay |
5 YEARS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
13/05/2019 |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A new method of ventral hernia repair in umbilical and incisional hernia has been devised and the effectiveness, post operative complication rate, pain assesment and post operative hospital stay and comparing with the routine laparoscopic and open methods of hernia repair is to be done. |