Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty

Study Overview
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Brief Summary
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The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) after Lichtenstein repair of groin hernia, depending on mesh type and fixation suture material. For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

Detailed Description
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This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in SHR, which covers > 95% of all groin hernia repairs in Sweden. The large database enables assessment of the relative risks for CPIP depending on in particular mesh and mesh fixation, adjusted for other plausible risk factors. Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. One year postop, each patient was sent a questionnaire focusing on present pain.

Official Title
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Mesh and Fixation Combinations in the Lichtenstein Groin Hernioplasty: Association With Chronic Postoperative Pain. A Swedish Hernia Registry Study.

Conditions
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Hernia, Inguinal, Hernia, Femoral, Postoperative Pain, Chronic Pain, PROM, Suture Related Complication

Intervention / Treatment
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* Device: Lichtenstein mesh repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All Lichtenstein and similar open mesh repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018. Exclusion Criteria: Laparoscopic repairs. Preperitoneal open repairs. Pure suture repairs Patients not having a 10-digit state-assigned Patient Identification Number.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Permanent suture<br>Mesh fixation with permanent suture | Device: Lichtenstein mesh repair<br>* A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures<br>|
| Long-term absorbable<br>Mesh fixation with long-term absorbable suture | Device: Lichtenstein mesh repair<br>* A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures<br>|
| Short-term absorbable<br>Mesh fixation with short-term absorbable suture | Device: Lichtenstein mesh repair<br>* A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures<br>|
| Fibrin glue<br>Biologic glue/sealant produced from human donor blood | Device: Lichtenstein mesh repair<br>* A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures<br>|
| Progrip<br>Pre-fabricated absorbable fixation hooks, integrated in mesh. Progrip is a registered trademark owned by Medtronic | Device: Lichtenstein mesh repair<br>* A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPIP | Chronic postoperative inguinal pain | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Swedish Hernia Registry, Lichtenstein, Surgical mesh, Surgical sutures