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.
- Conditions
- Adult male patients of Inguinal Hernia
- Registration Number
- CTRI/2012/02/002451
- Lead Sponsor
- Director Administration SIMS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Male
- Target Recruitment
- 200
adult male patients of both direct and indirect inguinal hernia will be taken up for the study.
recurrent hernia co-morbid conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cost effectiveness & efficacy six months
- Secondary Outcome Measures
Name Time Method surgical site infection mesh rejection
Trial Locations
- Locations (1)
Saraswathi Institute of Medical Sciences
🇮🇳Ghaziabad, UTTAR PRADESH, India
Saraswathi Institute of Medical Sciences🇮🇳Ghaziabad, UTTAR PRADESH, IndiaDr Saurabh GoelPrincipal investigator9917100027drsaurabhnamita18@yahoo.co.in