Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
174 participants
OBSERVATIONAL
2015-06-25
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Peritoneal in Laparoscopic Ventral Hernia Repair 2
NCT04229940
Mini- or Less-Open Sublay Operation (MILOS) of Incisional Hernias
NCT03133000
Peritoneal Bridging in Laparoscopic Ventral Hernia Repair
NCT03344575
Short Term Outcomes of Laparoscopic Intraperitoneal Onlay Mesh With Facial Repair(IPOM-plus) for Ventral Hernia.
NCT04137172
Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation
NCT01183325
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ventral hernia repair
Endoscopic Mini/Less Open Repair
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Diakonie-Klinikum Stuttgart
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Dr. med. Dr.h.c. Bittner
Role: PRINCIPAL_INVESTIGATOR
unaffiliated, retirement
Dr. Bärbel Kraft
Role: STUDY_DIRECTOR
Diakonie-Klinikum Stuttgart
Dr. Jochen Schwarz
Role: STUDY_DIRECTOR
Hernienzentrum Rottenburg
Dr.Stefan Amann
Role: STUDY_DIRECTOR
Diakoneo Klinik Neudettelsau
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diakonie Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, Germany
Dr.Stefan Amann
Neuendettelsau, , Germany
Hernia Center
Rottenburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1/2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.