Endoscopic Mini/Less Open Sublay(EMILOS) Repair

Diakonie-Klinikum Stuttgart174 enrolled

Overview

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).

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.

Study Type

OBSERVATIONAL

Enrollment

174

Conditions

Hernia, Ventral

Interventions

Endoscopic Mini/Less Open Sublay RepairDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Diakonie Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, Germany

Dr.Stefan Amann

Neuendettelsau, Germany

Hernia Center

Rottenburg, Germany

Outcomes

Primary Outcomes

Number of patients with Hernia recurrence

prove of hernia defect and hernia sac by questionaire and clinical investigation

Time frame: 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

Time frame: three years

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: Three years

Data from ClinicalTrials.gov

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