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Endoscopic Mini/Less Open Sublay(EMILOS) Repair

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05912868
Acronym
EMILOS
Enrollment
174
Registered
2023-06-22
Start date
2015-06-25
Completion date
2022-12-31
Last updated
2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Ventral

Keywords

Umbilical hernias-Incisional hernias-EMILOS- .

Brief summary

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

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.

Interventions

DEVICEEndoscopic Mini/Less Open Sublay Repair

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).

Sponsors

Diakonie-Klinikum Stuttgart
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with Hernia recurrencethree yearsprove of hernia defect and hernia sac by questionaire and clinical investigation
Number of patients with bulging in the midline of abdominal wallthree yearsBulging without prove of a hernia defect by questionaire and clinical investigation

Secondary

MeasureTime frameDescription
Number of patients suffering from chronic painthree yearsAsking 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)
Number of patients complaining about a stiff abdominal wallthree yearsAsking by questionaire if the patient has problems to bend down and/or problems to tie shoestrings
Number of patients being satisfied with operationThree yearsAsking by questionaire if the patient is satisfied with operation and if he would like to have this operation a second time

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026