Endoscopic Mini/Less Open Sublay(EMILOS) Repair

Hernia, Ventral Clinical Trial

— EMILOS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05912868
• Other study ID #: 1/2016
• Status: Completed
• Start date: June 25, 2015
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2023
• Source: Diakonie-Klinikum Stuttgart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 31, 2022
• Est. primary completion date: January 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral

Intervention

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).

Locations

Country	Name	City	State
Germany	Dr.Stefan Amann	Neuendettelsau
Germany	Hernia Center	Rottenburg
Germany	Diakonie Klinikum Stuttgart	Stuttgart	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Diakonie-Klinikum Stuttgart

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with Hernia recurrence	prove of hernia defect and hernia sac by questionaire and clinical investigation	three years
Primary	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	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)	three years
Secondary	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	three years
Secondary	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	Three years