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NCT Number: NCT05912868

Endoscopic Mini/Less Open Sublay(EMILOS) 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).

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Key information

Conditions

HERNIA, VENTRAL Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonie Klinikum Stuttgart, Stuttgart, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Mini/Less Open Sublay Repair

Device

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).

Primary outcomes

  1. Number of patients with Hernia recurrence

    Time frame: three years

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

  2. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Diakonie-Klinikum Stuttgart

Other

Registry information

Official study title

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

Acronym: EMILOS

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jun 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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