A Randomized Multi-center Study of Tissue Glue Fixation of Optilene™ Mesh With Histoacryl™ or Self-gripping Parietex ProGrip™ Compared to Conventional Non-absorbable Suture Fixation of Ultrapro™ Mesh
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Inguinal Hernia
- Sponsor
- Kuopio University Hospital
- Enrollment
- 650
- Locations
- 1
- Primary Endpoint
- pain
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.
Detailed Description
Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.
Investigators
Hannu Paajanen
PhD, MD
Kuopio University Hospital
Eligibility Criteria
Inclusion Criteria
- •primary or recurrent inguinal hernia
- •unilateral or bilateral
Exclusion Criteria
- •femoral hernia
- •massive scrotal hernia
- •allergy to polypropylene
- •patient's refusal
Outcomes
Primary Outcomes
pain
Time Frame: 5 years
pain scores (VAS 0-10) preoperatively and after surgery
Secondary Outcomes
- costs(1 year)