Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair

Study Overview
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Brief Summary
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The primary aim of the present study was to show how a national clinical register combined with other nationwide administrative registers may serve as a tool for pre- and post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.

Detailed Description
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All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent elective primary laparoscopic incisional hernia repair between January 1st 2010 and December 31st 2016. To obtain 100% follow-up data from DHB will be combined with administrative data from the Danish National Patient register. Patients will be followed from initial hernia repair until reoperation for recurrence, death, emigration outside Denmark or end of follow-up (november 2017). Physiomesh and other mesh repairs will be propensity score matched. Each patient in the Physiomesh® group will be matched with two patients treated with one of the other synthetic meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson comorbidity index and size of hernia defect The primary outcome: Difference in risk for a reoperation for recurrence between patients operated with Physiomesh® and patients operated with another synthetic mesh designed for laparoscopic repair. The secondary outcome will be rates of 30-day readmission, 30-day reoperation for complications (excluding hernia recurrence) as well as 30- and 90-day mortality.

Official Title
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Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair

Conditions
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Hernia, Abdominal, Recurrence, Postoperative Complications

Intervention / Treatment
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* Device: Physiomesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients registered in the Danish Hernia Database for a laparoscopic incisional hernia repair Exclusion Criteria: If not registered for a laparoscopic incisional hernia repair in the Danish Hernia Database

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Register study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Physiomesh<br>Patients undergoing laparoscopic incisional hernia repair reinforced with a Physiomesh. | Device: Physiomesh<br>* difference in risk for recurrence and postoperative complication<br>* Other names: other mesh;|
| No Intervention: other mesh<br>Patients undergoing laparoscopic incisional hernia repair reinforced with other meshes than Physiomesh. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-operation for recurrence rate |  | up to 84 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day readmission rate |  | 30 day | 
| 30-reoperation for complication rate |  | 30 day |