Chronic Postoperative Pain After Laparoscopic Groin Hernia Repair

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) depending on different combinations of mesh and mesh fixation. 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 the Swedish Hernia Registry (SHR), which covers > 95% of all groin hernia repairs in Sweden. The very large cohort of approximately 25,000 primary TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enable assessment of the relative risks for CPIP depending on different combinations of mesh and mesh fixation. Each participant was entered at the date of surgery when demographic and intraoperative data were registered. The possible presence of CPIP after 1 year postoperative was evaluated with a PROM questionnaire.

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

Conditions
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Postoperative Pain, Chronic Pain

Intervention / Treatment
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* Procedure: TEP
* Procedure: TAPP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018. Exclusion Criteria: Open repairs. Hernioplasties that were converted from laparoscopic to open surgery. Previous hernioplasty in the same groin Surgery merely for hernia (eg obturator) other than lateral, medial or femoral. Age < 15 years. 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 |
| --- | --- |
| Standard polypropylene mesh<br>Density > 50 g/square meter | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Lightweight mesh<br>A mesh based on either polypropylene or polyester. Some variants contain purely 1 polymer. Others are composite, ie, contain also an absorbable material. The density < 50 g/square meter (when applicable, after partial absorption) | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Fixation with metal tacks<br>Non-absorbable metal staples or tacks | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Fixation with absorbable tacks<br>Absorbable synthetic staples or tacks | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Fibrin glue fixation<br>Biologic glue/sealant produced from human donor blood | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Non-fixation<br>Mesh is deployed without fixation | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| 3D mesh<br>A polypropylene mesh with a preformed anatomic shape corresponding to the inner preperitoneal curvature of the groin. The category does not differentiate between standard and lightweight variants. | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Progrip fixation<br>Absorbable (Velcro type of) microhooks. The particular meshes come with prefabricated Progrip microhooks. Progrip = Registered trademark. | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|
| Polyester mesh<br>Polyester-based mesh. This category does not differentiate between standard and lightweight variants | Procedure: TEP<br>* Laparoscopic totally extraperitoneal mesh repair of groin hernia<br>Procedure: TAPP<br>* Laparoscopic transabdominal mesh repair of groin hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative risk for postoperative pain at 1 year | Chronic postoperative inguinal pain, measured by the Short Form Inguinal Pain Questionnaire (sf-IPQ) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation | Reoperation due to recurrence, during the study period | 1-8 years |