Endoscopic Mini/Less Open Sublay(EMILOS) Repair

Completed

• Conditions: Hernia, Ventral
• Interventions: Device: Endoscopic Mini/Less Open Sublay Repair

• Registration Number: NCT05912868
• Lead Sponsor: Diakonie-Klinikum Stuttgart

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.

Study Timeline

• Study Start: 2015-06-25
• Primary Completion: 2021-01-27
• Study Completion: 2022-12-31
• Study First Submitted: 2023-02-15
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-20
• Last Update Submitted: 2023-06-20
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ventral hernia repair	Endoscopic Mini/Less Open Sublay Repair	Endoscopic Mini/Less Open Repair

Primary Outcome Measures

Name	Time	Method
Number of patients with Hernia recurrence	three years	prove of hernia defect and hernia sac by questionaire and clinical investigation
Number of patients with bulging in the midline of abdominal wall	three years	Bulging without prove of a hernia defect by questionaire and clinical investigation

Secondary Outcome Measures

Name	Time	Method
Number of patients suffering from chronic pain	three years	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)
Number of patients complaining about a stiff abdominal wall	three years	Asking by questionaire if the patient has problems to bend down and/or problems to tie shoestrings
Number of patients being satisfied with operation	Three years	Asking by questionaire if the patient is satisfied with operation and if he would like to have this operation a second time

Trial Locations

Locations (3)

Diakonie Klinikum Stuttgart; 🇩🇪 Stuttgart, Baden-Württemberg, Germany

Dr.Stefan Amann; 🇩🇪 Neuendettelsau, Germany

Hernia Center; 🇩🇪 Rottenburg, Germany