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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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