Inguinal Hernia, Pain
Conditions
Keywords
Inguinal hernia repair, Hernia, ProGrib self-fixating mesh, Biological mesh, Tack fixation
Brief summary
A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.
Detailed description
The primary aim of this study is to evaluate acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation. The ProGripTM laparoscopic self-fixating mesh has been approved for implantation to reinforce the abdominal wall during laparoscopic inguinal hernia repair (TAPP). The mesh delivers tack free fixation above and below the inguinal ligament potentially eliminating pain associated with traditional tack fixation. The present study is a prospective randomized clinical trial designed to collect information about complications such as acute and chronic pain and hernia recurrence rate from patients referred for laparoscopic inguinal hernia repair. Patients who qualify to take part in the study will be randomized for a procedure using either a self-gripping ProGrip mesh or a conventional polypropylene mesh attached with AbsorbaTackTM. Data will be collected from operations performed at 6 high volume hernia centers in Denmark. Patients eligible for study will be recruited from the referral list for inguinal hernia repair at each participating institution. Prior to scheduled surgery, patients will be consented and will complete a questionnaire on inguinal pain intensity and quality of life . The mesh will be placed intraperitoneally after the component separation is complete. The peritoneal layer will be closed with a V-loc stitch in both groups. After surgery, key clinical data will be recorded, such as type of mesh used, size of the hernia defect, number of tacks used etc. The participating patients will receive postoperative questionnaires following the first year after surgery.
Interventions
DEVICEParietex ProGrib self-fixating mesh
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.
DEVICETack fixation
Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.
Sponsors
Medtronic - MITG
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective, inguinal hernia repair * 18 years or older * Male gender * ASA physical classification system 1-3 * Informed consent
Exclusion criteria
* Patients with recurrent hernia, except patients operated in childhood without mesh application. * Patients with bilateral hernia * Patients with chronic pain * Patients in anticoagulation therapy * Previous major surgery in lower abdomen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients experiencing acute postoperative pain, using the NRS pain score. | 3 months |
| Number of patients with recurrent hernia. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life before and after surgery, using the Carolina Comfort Scale | 6 months |
| Number of patients experiencing chronic postoperative pain, using the NRS pain score. | 1 year |
Countries
Denmark
Contacts
Primary ContactMalene O Dinesen, MD PhD
Backup ContactMarie K Christensen, MD
Outcome results
None listed