Endoscopic Mini/Less Open Sublay(EMILOS) Repair

NCT05912868 | Completed

• 1 other identifier: 1/2016
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 3

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).

Conditions

Hernia, Ventral

Keywords

Umbilical hernias-Incisional hernias-EMILOS- .

Outcome Measures

Primary Outcomes (2)

• Number of patients with Hernia recurrence

  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

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

  three years

Secondary Outcomes (3)

• Number of patients suffering from chronic pain

  three years

• Number of patients complaining about a stiff abdominal wall

  three years

• Number of patients being satisfied with operation

  Three years

Study Arms (1)

Ventral hernia repair

Endoscopic Mini/Less Open Repair

Device: Endoscopic Mini/Less Open Sublay Repair

Interventions

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).

Ventral hernia repair

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Diakonie-Klinikum Stuttgart: lead

Study Sites (3)

Diakonie Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70176, Germany

Location

Dr.Stefan Amann

Neuendettelsau, Germany

Location

Hernia Center

Rottenburg, 72108, Germany

Location

Related Publications (9)

• 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.

  PMID: 27766419 BACKGROUND

• 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.

  PMID: 31292742 BACKGROUND

• 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.

  PMID: 31571064 BACKGROUND

• 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.

  PMID: 29342018 BACKGROUND

• 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.

  PMID: 25217109 BACKGROUND

• 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.

  PMID: 30604264 BACKGROUND

• 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.

  PMID: 28916960 BACKGROUND

• 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.

  PMID: 29620963 BACKGROUND

• 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.

  PMID: 30746364 BACKGROUND

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Dr. med. Dr.h.c. Bittner

  unaffiliated, retirement

  PRINCIPAL INVESTIGATOR

• Dr. Bärbel Kraft

  Diakonie-Klinikum Stuttgart

  STUDY DIRECTOR

• Dr. Jochen Schwarz

  Hernienzentrum Rottenburg

  STUDY DIRECTOR

• Dr.Stefan Amann

  Diakoneo Klinik Neudettelsau

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: June 22, 2023
• Study Start: June 25, 2015
• Primary Completion: January 27, 2021
• Study Completion: December 31, 2022
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3)