Comparing Pain After Laparoscopic Hernia Repair Using Two Different Types of Mesh Fixation

Study Overview
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Brief Summary
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A clinical study evaluating acute and chronic pain following laparoscopic inguinal hernia repair comparing the ProGripTM self- fixating mesh with tack fixation.

Detailed Description
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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.

Official Title
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A Clinical Study of Postoperative Pain Following Laparoscopic Transabdominal Preperitoneal Inguinal Hernioplasty. Comparing Parietex ProGrib With Tacks for Mesh Fixation

Conditions
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Inguinal Hernia, Pain

Intervention / Treatment
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* Device: Parietex ProGrib self-fixating mesh
* Device: Tack fixation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-fixating mesh<br>During surgery, the Parietex ProGrib mesh will be used. | Device: Parietex ProGrib self-fixating mesh<br>* Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.<br>|
| Active Comparator: Tack fixation<br>During surgery, the mesh will be fixated with tacks. | Device: Tack fixation<br>* Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients experiencing chronic postoperative pain, using the NRS pain score. |  | 1 year | 
| Quality of life before and after surgery, using the Carolina Comfort Scale |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal hernia repair, Hernia, ProGrib self-fixating mesh, Biological mesh, Tack fixation