Endoscopic Mini/Less Open Sublay(EMILOS) Repair

Study Overview
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Brief Summary
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Ventral hernias in the midline of the abdominal wall are one of the most frequent diseases in general and visceral surgery worldwide. The optimal operative technique is still in discussion. The traditional techniques are open sublay or transabdominal intraperitoneal onlay mesh (IPOM) repair. In order to avoid the risks -large trauma to the abdominal wall with pain and infection, lesion of intraabdominal organs - a new hybrid technique - small skin incision, wide endoscopic dissection of the retrorectus space with implantation of a large mesh - was developed (EMILOS -Endoscopic Mini/Less Open Sublay).

Detailed Description
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Long-term results in 174 patients with a ventral hernia of the abdominal wall after EMILOS (Endoscopic Mini/Less Open Sublay) repair. The worldwide most frequently used surgical techniques to repair ventral abdominal wall hernias are the open sublay operation and the transabdominal IPOM (Intra-Peritoneal Onlay Mesh) technique. Therefore a special questionnaire was developed to send to the patients to evaluate long-term outcome.

Official Title
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Long-term Results in 174 Patients With a Ventral Hernia in the Midline of the Abdominal Wall After EMILOS (Endoscopic Mini/Less Open Sublay) Repair

Conditions
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Hernia, Ventral

Intervention / Treatment
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* Device: Endoscopic Mini/Less Open Sublay Repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients with clinical diagnosis of primary or secondary hernia in the midline of the abdominal wall Defect size must be between 2 and 10 cm in width associated with a weak abdominal wall(rectus diastasis) Patient must be suitable for general anesthesia Patient must have given informed consent Patient must be able to understand the principles of operation Patient must agree to be incluuded in a follow-up program and to be documented in Herniamed registry Exclusion Criteria: Patients below 18 years of age Patients with a defect size below 2 cm Patients presenting with loss of domain Patients not be able to tolerate general anesthesia Patients presenting with excess skin tissue

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Ventral hernia repair<br>Endoscopic Mini/Less Open Repair | Device: Endoscopic Mini/Less Open Sublay Repair<br>* The traditional techniques are open sublay or transabdominal intraperitoneal onlay mesh (IPOM) repair. In order to avoid the risks -large trauma to the abdominal wall with pain and infection, lesion of intraabdominal organs - a new hybrid technique - small skin incision, wide endoscopic dissection of the retrorectus space with implantation of a large mesh - was developed (EMILOS -Endoscopic Mini/Less Open Sublay).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Hernia recurrence | prove of hernia defect and hernia sac by questionaire and clinical investigation | three years | 
| Number of patients with bulging in the midline of abdominal wall | Bulging without prove of a hernia defect by questionaire and clinical investigation | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients suffering from chronic pain | Asking by questionaire if the patient has pain at rest and under stress in the region of the scar resp. the former hernia defect measured by numeric analog scale (NAS) | three years | 
| Number of patients complaining about a stiff abdominal wall | Asking by questionaire if the patient has problems to bend down and/or problems to tie shoestrings | three years | 
| Number of patients being satisfied with operation | Asking by questionaire if the patient is satisfied with operation and if he would like to have this operation a second time | Three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical hernias-Incisional hernias-EMILOS- .