A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Inguinal Hernia
- Sponsor
- Medical University of Vienna
- Enrollment
- 250
- Locations
- 7
- Primary Endpoint
- chronic pain
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.
A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.
Two techniques of inguinal hernia repair will be evaluated:
- open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
- open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)
Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.
Investigators
Eligibility Criteria
Inclusion Criteria
- •primary unilateral inguinal hernia
- •18 years and older
Exclusion Criteria
- •bilateral hernia
- •recurrent hernia
- •incarcerated hernia
- •malignant disease within the last 5 years
- •not able to understand the questionaire
Outcomes
Primary Outcomes
chronic pain
Time Frame: 3 months, 15 months
Secondary Outcomes
- morbidity(3 months, 15 months)
- recurrence rate(3 months and 15 months)
- quality of life(3 months and 15 months)