Mini- or Less-Open Sublay Operation (MILOS) of Incisional Hernias

Study Overview
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Brief Summary
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Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Hernia Center of Reference of Gross Sand Hospital using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The data of all patients were prospectively documented in the German Hernia Registry Herniamed. The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.

Detailed Description
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Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Reference Hernia Center of Gross Sand Hospital between 1 January 2010 and 30 September 2015 using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.The data of all patients were prospectively documented in the German Hernia Registry Herniamed. Data privacy protection was strictly implemented according to German federal law. All patients were informed in detail about the new surgical technique, other treatment options, prospective register study with one year questionnaire follow-up, data documentation. All patients gave written consent. A propensity score matching of all patients of the MILOS-cohort of Gross Sand Hospital with patients with comparable incisional hernias who were operated on using the laparoscopic intraperitoneal onlay mesh (IPOM) technique or open sublay technique in other institutions participating in the German Hernia Database Herniated was performed.

Official Title
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Mini- or Less-Open Sublay Operation (MILOS) - a New Minimally Invasive Technique for the Extraperitoneal Repair of Incisional Hernias

Conditions
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Incisional Hernia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with symptomatic elective primary or secondary incisional hernias: Median incisional hernias Lateral incisional hernias Exclusion Criteria: Emergencies Very large incisional hernias that required incisions larger than 12 cm

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence after incisional hernia repair as assess by clinical examination at one year | Data collected in German National Hernia Registry (Herniamed) | one year follow-up | 
| Chronic pain after incisional hernia repair as reported by questionnaire and follow up examination at one year | Data collected in German National Hernia Registry (Herniamed) | one year follow-up | 
| Perioperative complications after incisional hernia repair | Data collected in German National Hernia Registry (Herniamed) | one year follow-up | 
| Reoperation after incisional hernia repair | Data collected in German National Hernia Registry (Herniamed) | one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent abdominal wall hernia, Incisional hernia