CTRI Number |
CTRI/2012/02/002451 [Registered on: 27/02/2012] Trial Registered Prospectively |
Last Modified On: |
28/03/2012 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Non-randomized, Active Controlled Trial |
Public Title of Study
|
A clinical trial to compare the efficacy and cost effectiveness between knitted monofilament of polyethylene and monofilament of polypropylene mesh in case of adult inguinal hernia. |
Scientific Title of Study
|
A non-randomized prospective study of efficacy and cost effectiveness between knitted monofilament of polyethylene and monofilament of polypropylene mesh in case of adult inguinal hernia. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrSKThakur |
Designation |
Professor |
Affiliation |
Saraswathi Institute of Medical Sciences |
Address |
Saraswathi Institute of Medical Sciences NH-24, Anwarpur, Pilakhuwa, Hapur, Distt. Ghaziabad (UP)
Ghaziabad UTTAR PRADESH 245304 India |
Phone |
9219579628 |
Fax |
01222320111 |
Email |
thakur_sk@rediffmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Saurabh Goel |
Designation |
Assistant Professor |
Affiliation |
Saraswathi Institute of Medical Sciences |
Address |
Saraswathi Institute of Medical Sciences NH-24, Anwarpur, Pilakhuwa, Hapur, Distt. Ghaziabad (UP)
Ghaziabad UTTAR PRADESH 245304 India |
Phone |
9917100027 |
Fax |
01222320111 |
Email |
drsaurabhnamita18@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Premprakash |
Designation |
Assistant Professor |
Affiliation |
|
Address |
Saraswathi Institute of Medical Sciences NH-24, Anwarpur, Pilakhuwa, Hapur, Distt. Ghaziabad (UP)
Ghaziabad UTTAR PRADESH 245304 India |
Phone |
8057381555 |
Fax |
|
Email |
drpremprakash01@yahoo.co.in |
|
Source of Monetary or Material Support
|
Saraswathi Institute of Medical Sciences |
|
Primary Sponsor
|
Name |
Director Administration SIMS |
Address |
Saraswathi Institute of Medical Sciences, Pilkhuwa,Hapur,Ghaziabad Saraswathi Institute of Medical Sciences NH-24, Anwarpur, Pilakhuwa, Hapur, Distt. Ghaziabad (UP) Pincode - 2453 |
Type of Sponsor |
Private 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 Saurabh Goel |
Saraswathi Institute of Medical Sciences |
Dept of Surgery
IInd floor
Old Hospital Block Saraswathi Institute of Medical Sciences NH-24, Anwarpur, Pilakhuwa, Hapur, Distt. Ghaziabad (UP) Pincode - 245304 Ghaziabad UTTAR PRADESH |
9917100027 0122-2320111 drsaurabhnamita18@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee of Saraswathi Institute of Medical Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Adult male patients of Inguinal Hernia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
branded mesh(comparator),it is being routinely used |
Knitted monofilament of Polypropylene mesh |
Intervention |
local mesh(intervention) |
Knitted monofilament of Polyethylene mesh |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Male |
Details |
adult male patients of both direct and indirect inguinal hernia will be taken up for the study |
|
ExclusionCriteria |
Details |
recurrent hernia
co-morbid conditions
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Cost effectiveness & efficacy |
six months |
|
Secondary Outcome
|
Outcome |
TimePoints |
surgical site infection
mesh rejection
recurrence |
3 years |
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
01/03/2012 |
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="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Preliminary Multicentric Trial of Cheap Indigenous Mosquito-Net Cloth for Tension-free Hernia Repair
Indian Journal of Surgery, Vol. 65, No. 1, Jan.-Feb. 2003, pp. 89-95
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
This is a non- randomized prospective clinical trial. The aim and objective of this trial is to compare the efficacy and cost effective methods for inguinal hernia repair in adults. Today in major cities of our country, Laparoscopic hernia repair is being done routinely but still it is not affordable to the poor patients of this country, who form the major chunk of the population. Keeping in view this fact, the clinical trial will be performed on 200 patients needing hernioplasty. There will be two groups of participants, group1( polypropylene mesh) and group2 (polyethylene mesh). All the surgeries will be done by trained surgeons already working in the hospital. The Surgery will be done preferably under local anesthesia. The direct cost incurred by the patient will be calculated and they will be followed up for minimum three years for post operative complications and the result will be compared with respect to complications. For the control as well as intervention group 100 patients each will be selected. The patient will have option to choose the mesh. To avoid any bias by any member of the team, the pros and cons of branded and local mesh will be explained to the patient by a doctor not related with this team. The indigenous polyethylene mesh is costing Rs. 20/- while polypropylene mesh is costing Rs 950/- approximately(6*3 inches) to the patient. |