Clinical Trial: Mini- or Less-Open Sublay Operation (MILOS) of Incisional Hernias

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Mini- or Less-Open Sublay Operation (MILOS) - a New Minimally Invasive Technique for the Extraperitoneal Repair of Incisional Hernias

Brief Summary: Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Hernia Center of Reference of Gross Sand Hospital using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The data of all patients were prospectively documented in the German Hernia Registry "Herniamed". The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.

Detailed Summary:

Prospective non-randomized observational register study of all elective symptomatic incisional hernias operated on in the Reference Hernia Center of Gross Sand Hospital between 1 January 2010 and 30 September 2015 using the novel endoscopic assisted Mini- or Less-Open Sublay technique. The novel MILOS-technique allows the minimal invasive implantation of large extraperitoneal meshes for the treatment of primary and secondary incisional hernias.The data of all patients were prospectively documented in the German Hernia Registry "Herniamed". Data privacy protection was strictly implemented according to German federal law. All patients were informed in detail about the new surgical technique, other treatment options, prospective register study with one year questionnaire follow-up, data documentation. All patients gave written consent.

A propensity score matching of all patients of the MILOS-cohort of Gross Sand Hospital with patients with comparable incisional hernias who were operated on using the laparoscopic intraperitoneal onlay mesh (IPOM) technique or open sublay technique in other institutions participating in the German Hernia Database "Herniated" was performed.


Sponsor: Gross Sand Hospital

Current Primary Outcome:

  • Recurrence after incisional hernia repair as assess by clinical examination at one year [ Time Frame: one year follow-up ]
    Data collected in German National Hernia Registry (Herniamed)
  • Chronic pain after incisional hernia repair as reported by questionnaire and follow up examination at one year [ Time Frame: one year follow-up ]
    Data collected in German National Hernia Registry (Herniamed)
  • Perioperative complications after incisional hernia repair [ Time Frame: one year follow-up ]
    Data collected in German National Hernia Registry (Herniamed)
  • Reoperation after incisional hernia repair [ Time Frame: one year follow-up ]
    Data collected in German National Hernia Registry (Herniamed)


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gross Sand Hospital

Dates:
Date Received: April 17, 2017
Date Started: January 1, 2010
Date Completion:
Last Updated: April 25, 2017
Last Verified: April 2017