Factors Influencing the Results of Treatment in Patients With Hernias of Various Localizations

Study Overview
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Brief Summary
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The study attempts to quantify the relative risks for acute postoperative pain, complications rate, chronic postoperative pain (CPIP) and recurrence rate after different methods of repair of groin, umbilical and incisional hernia depending on surgical technique, mesh type and fixation suture material. For this purpose the investigators will analyze data from the Kalinigrad Hernia Registry (KHR).

Official Title
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Factors Affecting the Results of Treatment of Patients With Hernias of Various Localization: Evaluation of Treatment Results Using an Automated Hernia Register

Conditions
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Inguinal Hernia, Femoral Hernia, Umbilical Hernia, Ventral Hernia, Chronic Pain, Acute Post Operative Pain, Recrrence Rate

Intervention / Treatment
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* Procedure: open non-mesh hernia repair
* Procedure: open mesh hernia repair
* Procedure: MIS hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All mesh and non-mesh repairs that have been registered in the KHR from January 9, 2020, until December 31, 2023. Exclusion Criteria: Patients not having a 11-digit state-assigned Personal insurance policy number. Parastomal hernia; infected hernias;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Patients with groin and femoral hernia/IG<br> | Procedure: open non-mesh hernia repair<br>* A groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair.<br>Procedure: open mesh hernia repair<br>* A groin and femoral hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures for Lichtenstein. Self-fixating mesh is also possible. An umbilical, ventral, incisional hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures.<br>Procedure: MIS hernia repair<br>* A groin and femoral minimal invasive hernia repair (TAPP, eTEP). The mesh is affixed with tack/no-fixation. Self-fixation mesh is also possible. An umbilical, ventral, incisional minimal invasive hernia repair (eTEP, IPOM,). The mesh is affixed with tack and no-fixation .<br>|
| Patients with umbilical hernia/IG<br> | Procedure: open non-mesh hernia repair<br>* A groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair.<br>Procedure: open mesh hernia repair<br>* A groin and femoral hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures for Lichtenstein. Self-fixating mesh is also possible. An umbilical, ventral, incisional hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures.<br>Procedure: MIS hernia repair<br>* A groin and femoral minimal invasive hernia repair (TAPP, eTEP). The mesh is affixed with tack/no-fixation. Self-fixation mesh is also possible. An umbilical, ventral, incisional minimal invasive hernia repair (eTEP, IPOM,). The mesh is affixed with tack and no-fixation .<br>|
| Patients with ventral and incisional hernia/InG<br> | Procedure: open non-mesh hernia repair<br>* A groin and femoral hernia non-mesh repair. An umbilical hernia non-mesh repair. A ventral and incisional hernia non-mesh repair.<br>Procedure: open mesh hernia repair<br>* A groin and femoral hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures for Lichtenstein. Self-fixating mesh is also possible. An umbilical, ventral, incisional hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures.<br>Procedure: MIS hernia repair<br>* A groin and femoral minimal invasive hernia repair (TAPP, eTEP). The mesh is affixed with tack/no-fixation. Self-fixation mesh is also possible. An umbilical, ventral, incisional minimal invasive hernia repair (eTEP, IPOM,). The mesh is affixed with tack and no-fixation .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic postoperative pain rate and severity | The painDETECT questionnaire will be used to identify chronic postoperative pain. Final painDETECT Score: 20, indicating that a neuropathic pain component is likely (>90%). | 1 year | 
| Recurrence rate | the overall frequency of recurrent hernias | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment satisfaction rate | To assess the quality of life will be used Eura HS Quality of Life Scale-EuraHS QoL. EuraHS Qol - total (min - 0, max - 90) EuraHS Qol - pain (min - 0, max - 30) EuraHS Qol - restriction of activities (min - 0, max - 40) EuraHS Qol - cosmetic discomfort (min -0, max - 20) Higher scores mean a worse outcome. | 3 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia, register, inguinal hernia, femoral hernia, umbilical hernia, ventral hernia, CPIP, postoperative complications, chronic post-operative pain, recurrence rate