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Hernia, VentralEMILOSNCT05912868

Endoscopic Mini/Less Open Sublay(EMILOS) Repair

An observational study of Hernia, Ventral, run by Diakonie-Klinikum Stuttgart at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hernia, Ventral
What is being tested?
Endoscopic Mini/Less Open Sublay Repair
Type of treatment
Medical device
How many people
174 participants
Where
3 sitesGermany
Study dates
25 Jun 2015to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Dr.Stefan Amann

    Neuendettelsau

  • Hernia Center

    Rottenburg, 72108

  • Diakonie Klinikum Stuttgart

    Stuttgart, Baden-Wurttemberg, 70176

Other trials in Germany

About this study

Official 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

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).

Read the 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.

Conditions
Hernia, Ventral
Being tested
Endoscopic Mini/Less Open Sublay Repair
Keywords
Umbilical hernias-Incisional hernias-EMILOS- .
Medical subject headings
Hernia, Ventral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT05912868
Study groupRoleWhat they receive
Ventral hernia repairEndoscopic Mini/Less Open Repair
Receives: Device: Endoscopic Mini/Less Open Sublay Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with Hernia recurrence

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

    Measured: three years

  2. Number of patients with bulging in the midline of abdominal wall

    Bulging without prove of a hernia defect by questionaire and clinical investigation

    Measured: three years

Secondary outcomes (3)

  1. 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)

    Measured: three years

  2. 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

    Measured: three years

  3. 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

    Measured: Three years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start25 Jun 2015
  3. Primary completion27 Jan 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05912868
Sponsor's protocol ID
1/2016
Acronym
EMILOS
Status last verified
Jun 2023
First submitted
15 Feb 2023
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwarz J, Reinpold W, Bittner R. Endoscopic mini/less open sublay technique (EMILOS)-a new technique for ventral hernia repair. Langenbecks Arch Surg. 2017 Feb;402(1):173-180. doi: 10.1007/s00423-016-1522-0. Epub 2016 Oct 20.

    PubMed 27766419

  • Bittner R, Bain K, Bansal VK, Berrevoet F, Bingener-Casey J, Chen D, Chen J, Chowbey P, Dietz UA, de Beaux A, Ferzli G, Fortelny R, Hoffmann H, Iskander M, Ji Z, Jorgensen LN, Khullar R, Kirchhoff P, Kockerling F, Kukleta J, LeBlanc K, Li J, Lomanto D, Mayer F, Meytes V, Misra M, Morales-Conde S, Niebuhr H, Radvinsky D, Ramshaw B, Ranev D, Reinpold W, Sharma A, Schrittwieser R, Stechemesser B, Sutedja B, Tang J, Warren J, Weyhe D, Wiegering A, Woeste G, Yao Q. Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)): Part B. Surg Endosc. 2019 Nov;33(11):3511-3549. doi: 10.1007/s00464-019-06908-6. Epub 2019 Jul 10.

    PubMed 31292742

  • Reinpold W, Schroder M, Berger C, Stoltenberg W, Kockerling F. MILOS and EMILOS repair of primary umbilical and epigastric hernias. Hernia. 2019 Oct;23(5):935-944. doi: 10.1007/s10029-019-02056-x. Epub 2019 Sep 30.

    PubMed 31571064

  • Reinpold W, Schroder M, Berger C, Nehls J, Schroder A, Hukauf M, Kockerling F, Bittner R. Mini- or Less-open Sublay Operation (MILOS): A New Minimally Invasive Technique for the Extraperitoneal Mesh Repair of Incisional Hernias. Ann Surg. 2019 Apr;269(4):748-755. doi: 10.1097/SLA.0000000000002661.

    PubMed 29342018

  • Kohler G, Luketina RR, Emmanuel K. Sutured repair of primary small umbilical and epigastric hernias: concomitant rectus diastasis is a significant risk factor for recurrence. World J Surg. 2015 Jan;39(1):121-6; discussion 127.. doi: 10.1007/s00268-014-2765-y.

    PubMed 25217109

  • Kockerling F, Simon T, Adolf D, Kockerling D, Mayer F, Reinpold W, Weyhe D, Bittner R. Laparoscopic IPOM versus open sublay technique for elective incisional hernia repair: a registry-based, propensity score-matched comparison of 9907 patients. Surg Endosc. 2019 Oct;33(10):3361-3369. doi: 10.1007/s00464-018-06629-2. Epub 2019 Jan 2.

    PubMed 30604264

  • Belyansky I, Daes J, Radu VG, Balasubramanian R, Reza Zahiri H, Weltz AS, Sibia US, Park A, Novitsky Y. A novel approach using the enhanced-view totally extraperitoneal (eTEP) technique for laparoscopic retromuscular hernia repair. Surg Endosc. 2018 Mar;32(3):1525-1532. doi: 10.1007/s00464-017-5840-2. Epub 2017 Sep 15.

    PubMed 28916960

  • Kohler G, Fischer I, Kaltenbock R, Schrittwieser R. Minimal Invasive Linea Alba Reconstruction for the Treatment of Umbilical and Epigastric Hernias with Coexisting Rectus Abdominis Diastasis. J Laparoendosc Adv Surg Tech A. 2018 Oct;28(10):1223-1228. doi: 10.1089/lap.2018.0018. Epub 2018 Apr 5.

    PubMed 29620963

  • Reinpold W, Kockerling F, Bittner R, Conze J, Fortelny R, Koch A, Kukleta J, Kuthe A, Lorenz R, Stechemesser B. Classification of Rectus Diastasis-A Proposal by the German Hernia Society (DHG) and the International Endohernia Society (IEHS). Front Surg. 2019 Jan 28;6:1. doi: 10.3389/fsurg.2019.00001. eCollection 2019.

    PubMed 30746364

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia, Ventral, run by Diakonie-Klinikum Stuttgart at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with Hernia recurrence (time frame: three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05912868, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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