| CTRI Number |
CTRI/2019/05/019006 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
07/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison between laparoscopic repair of inguinal hernia by using two different mesh. |
|
Scientific Title of Study
|
Prospective comparative study of laproscopic totally extraperitoneal repair for inguinal hernia with light weight polypropylene mesh v/s 3D anatomically shaped large pore polypropylene mesh. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jekee B Patel |
| Designation |
First year resident,General Surgery |
| Affiliation |
GMC ,Bhavnagar. |
| Address |
Department of General Surgery, Sir T. Hostpital,Jail Road,Bhavnagar-364001,Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427248909 |
| Fax |
|
| Email |
pateljekee94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samir M Shah |
| Designation |
Professor & Head |
| Affiliation |
GMC ,Bhavnagar. |
| Address |
Department of General Surgery, Sir T. Hostpital,Jail Road,Bhavnagar-364001,Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427215253 |
| Fax |
|
| Email |
shah.samir@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jekee B Patel |
| Designation |
First year resident,General Surgery |
| Affiliation |
GMC ,Bhavnagar. |
| Address |
Department of General Surgery, Sir T. Hostpital,Jail Road,Bhavnagar-364001,Gujarat
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427248909 |
| Fax |
|
| Email |
pateljekee94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery,Sir T Hospital,Jail Road,Bhavnagar,Gujarat-364001 |
|
|
Primary Sponsor
|
| Name |
Department of Surgery |
| Address |
Department of General Surgery,Sir T Hospital,Jail Road,Bhavnagar,Gujarat-364001 |
| 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 Jekee B Patel |
Sir T Hospital |
Department of Surgery,Sir T hospital,Jail Road,Bhavnagar,Gujarat-364001
Bhavnagar
GUJARAT |
9427248909
pateljekee94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board,GMC Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40||Inguinal hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic totally extraperitoneal repair for inguinal hernia |
Laparoscopic totally extraperitoneal repair for inguinal hernia with 3D anatomically shaped large pore polypropylene mesh |
| Comparator Agent |
Laparoscopic totally extraperitoneal repair for inguinal hernia |
laproscopic totally extraperitoneal repair for inguinal hernia with light weight polypropylene mesh |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All the patients of age between 20 to 80 years |
|
| ExclusionCriteria |
| Details |
Patient having history of Preperitoneal surgery done.
Patient who are unfit for general anestheisa.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To achieve laparoscopic totally extraperitoneal inguinal hernia repair with least post operative pain and complications .
Time taken for mesh fixation.
Length of hospital stay . |
3 days
1 week
2 week
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for discharge from the hospital.
Least chances of recurrence. |
1 week
2 week
1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
17/05/2019 |
| 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
|
1. Kingsnorth A, Leblanc K. Hernias: Inguinal and Incisional. Lancet. 2003;362(9395):1561-71. 2. Usher F. Hernia Repair with Marlex Mesh Arch. Surg. 1962;84:325-8. 3. Ger R. The Management of certain abdominal hernias by intra-abdominal closure of the neck. Ann. R. Coll. Surg. Engl. 1982;64;342-4. 4. Bracale U, Melillo P, Pignata G, Di Salvo E, Rovani M, Merola G, et al. Which is the best laparoscopic approach for inguinal hernia repair: TEP or TAPP? A systematic review of the literature with a network meta-analysis. Surg Endosc. 2012;26:3355-66. 5. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years’ experience with 850 consecutive hernias |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study regarding laparoscopic totally extraperitoneal repair of inguinal hernia , two groups of 25-25 patients-total sample size of 50 patients selected randomly - will be compared in terms of inguinal hernia repair by light weight polypropylene mesh v/s 3D anatomically shaped large pore polypropylene mesh.Outcome in terms of which method is better and has least post operative hospital stay along with least complications will be measured. |