Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery

Study Overview
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Brief Summary
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The study attempts to quantify the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type. 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 more than 38,000 TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enables assessment of the relative risks for recurrence depending on complex combinations of plausible risk factors, in particular mesh, mesh fixation, hernia size and hernia type, with fulfilling statistical power. Each participant was entered at the date of surgery, when demographic and intraoperative data were registered. Reoperations were registered in the SHR in the same manner as index repairs, and were used as endpoints.

Official Title
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Mesh and Mesh Fixation in Laparoscopic Groin Hernia Surgery: A Swedish Hernia Registry Study

Conditions
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Hernia, Inguinal, Surgical Mesh, Laparoscopy, Hernia, Hernia, Femoral, Surgical Procedures, Minimally Invasive, Surgical Staplers, Recurrence, Fixation Device; Complications

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 (mainly TEP and TAPP) repairs that have been registered in the SHR from January 1, 2005 until December 31, 2018. Exclusion Criteria: Open repairs. Hernioplasties that were converted from laparoscopic to open surgery. 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 |
| --- | --- |
| StdPPM<br>Standard pure polypropylene mesh. Standard is defined in SHR by weight ≥ 50 g/square meter. | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| LWM<br>Lightweight mesh: Either a pure polypropylene mesh, or a polypropylene-based composite mesh. The study uses SHR's classification of light-weight = <50 g/square meter. | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| Tacks, metal<br>Metal staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| Tacks, absorbable<br>Absorbable synthetic staples or tacks. Material specification of staples/tacks was introduced in SHR 2012. | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| Tacks, uncategorized<br>Staples or tacks were in SHR 2005-2011 not further categorized. This category also includes staples/tacks registered from 2012 and forth, not being specified as either metal or absorbable. | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| Fibrin glue<br>Biologic glue/sealant produced from human donor blood | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| Non-fixation<br>Mesh is deployed without fixation | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|
| 3D Mesh<br>Mesh categorized by anatomical shaped, rather than material or weight. Therefore, this category will be excluded in the original study. Depending on the volume of casess found, the 3D mesh category may eventually be analyzed separately in another study.. | Procedure: TEP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic totally extraperitoneal mesh repair;Procedure: TAPP<br>* By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device<br>* Other names: Laparoscopic transabdominal preperitoneal mesh repair;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperation for recurrence | The date of the recurrent surgery | Assessment at Dec 31, 2018 | 
| Death | The date of death | Assessment at Dec 31, 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Totally extraperitoneal, Transabdominal preperitoneal, Fibrin glue, Fibrin sealant, Mesh fixation, Fixation devices