Endoscopic Mini/Less Open Sublay(EMILOS) Repair (EMILOS)

June 20, 2023 updated by: Diakonie-Klinikum Stuttgart

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuendettelsau, Germany
        • Dr.Stefan Amann
      • Rottenburg, Germany, 72108
        • Hernia Center
    • Baden-Württemberg
      • Stuttgart, Baden-Württemberg, Germany, 70176
        • Diakonie Klinikum Stuttgart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients visiting the ambulance of one of the three participating hospitals because of pain or a bulge in the midline of the abdominal wall without previous or after previous abdominal operation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ventral hernia repair
Endoscopic Mini/Less Open Repair
Device: Endoscopic 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with Hernia recurrence
Time Frame: three years
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
Time Frame: three years
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
Time Frame: 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)
three years
Number of patients complaining about a stiff abdominal wall
Time Frame: three years
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
Time Frame: Three years
Asking by questionaire if the patient is satisfied with operation and if he would like to have this operation a second time
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diakonie-Klinikum Stuttgart

Investigators

  • Principal Investigator: Prof. Dr. med. Dr.h.c. Bittner, unaffiliated, retirement
  • Study Director: Dr. Bärbel Kraft, Diakonie-Klinikum Stuttgart
  • Study Director: Dr. Jochen Schwarz, Hernienzentrum Rottenburg
  • Study Director: Dr.Stefan Amann, Diakoneo Klinik Neudettelsau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2015

Primary Completion (Actual)

January 27, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

June 20, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 20, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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