| CTRI Number |
CTRI/2009/091/000020 [Registered on: 03/05/2010] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
Comparing non-fixation of mesh to mesh fixation in laparoscopic inguinal hernia repair |
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Scientific Title of Study
|
Comparing non-fixation of mesh to mesh fixation in laparoscopic total extraperitoneal inguinal hernia repair under spinal anesthesia- A randomized Controlled Trial |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Garg |
| Designation |
|
| Affiliation |
|
| Address |
1139
sector-11
Panchkula
HARYANA
134112
India |
| Phone |
09501011000 |
| Fax |
0172-4648741 |
| Email |
drgargpankaj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Garg |
| Designation |
|
| Affiliation |
|
| Address |
1139
sector-11
Panchkula
HARYANA
134112
India |
| Phone |
09501011000 |
| Fax |
|
| Email |
drgargpankaj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Garg |
| Designation |
|
| Affiliation |
|
| Address |
1139
sector-11
Panchkula
HARYANA
134112
India |
| Phone |
09501011000 |
| Fax |
|
| Email |
drgargpankaj@yahoo.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
Self |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohamed Ismail |
Moulana Hospital |
,-
|
09447128511
mdismail13@gmail.com |
|
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Moulana Hospital Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Inguinal Hernia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mesh Fixation |
Two tacks(staples) will be used in cases where the mesh will be fixed |
| Comparator Agent |
Mesh Not fixed |
The mesh is not fixed at all in these cases. |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
All reducible inguinal hernias will be included in the study. |
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| ExclusionCriteria |
| Details |
Irreducible hernia after anesthesia, obstructed and strangulated hernias, pediatric hernias and patients with associated other hernias like ventral hernias will be excluded from the study. Patients unfit for spinal anesthesia will also be excluded from the study. |
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence rate |
6 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Pain |
Post operative-6 hours, 24 hours, 1 week |
| Days to resume work |
1 week |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/08/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
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Hernia repair is one of the most common surgery performed all over the world. The same is true about India. With more than a billion population, the number of hernia patients in our country perhaps run in millions. The laparoscopic repair is increasingly becoming popular in India.
Decreased post operative pain and lesser morbidity are the main advantages of Total Extra Peritoneal Repair (TEP) over open hernia repair. Laparoscopic hernia repair is now recommended as the method of choice for bilateral and recurrent inguinal hernias. The disadvantages of TEP are requirement of general anesthesia (GA), need to fix the mesh, seroma formation and difficult learning curve. Fixation of mesh with metal staples, apart from increasing the cost, may lead to new post operative groin pain which even becomes chronic in small percentage of patients. This had led to various studies showing that the non-fixation of mesh is safe, cost effective and lead to no increased risk of hernia recurrence compared to the conventional open hernia repair10-16. Requirement of GA for TEP repair also had several disadvantages compared to regional anesthesia such as significant hemodynamic changes, delayed recovery, post operative nausea and vomiting, increased cost and inability to give anesthesia in high cardio-pulmonary risk patients. Several studies in recent past have demonstrated TEP is feasible and safe in regional anesthesia (epidural or spinal) as well. We reported that TEP repair could be done without fixation of the mesh under regional anesthesia. A retrospective analysis of recurrence rates, post operative pain outcomes and other morbidity factors was done in 1289 hernia repairs in 675 patients. Laparoscopic TEP hernia repair done under spinal anesthesia with non fixation of the mesh was compared to repairs done under general anesthesia with non fixation of the mesh and repairs done under spinal anesthesia (SA) with fixation of mesh. The results showed that TEP, done under SA and without fixation of the mesh, was safe, feasible and associated with recurrence rate, which was low and similar to TEP hernia repair done with fixation of the mesh or under general anesthesia. Since this procedure (TEP done under regional anesthesia without fixation of the mesh) didn?t have the disadvantages usually attributed to TEP (need for GA and fixation of mesh), it could perhaps be suggested as a first line procedure even for unilateral inguinal hernias.
This study is a Randomized Controlled Trial (RCT) comparing the outcome of non-fixation of mesh during laparoscopic inguinal hernia repair with fixation of mesh under spinal anesthesia. The end points measured would be the recurrence level and pain in the post operative period. The patients undergoing laparoscopic total extra peritoneal (TEP) inguinal hernia repair under spinal anesthesia would be randomized in to either of the two groups- Fixation of mesh and Non-fixation of Mesh. The purpose of the study is
? To verify the safety and efficacy of the laparoscopic total extra peritoneal inguinal hernia repair without fixation of the mesh under spinal anesthesia
? To test whether non-fixation of mesh leads to less pain compared to the repair when the mesh is fixed.
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