Clinical trial NCT03133000: Mini- or Less-Open Sublay Operation (MILOS) of Incisional Hernias
Official title: Mini- or Less-Open Sublay Operation (MILOS) - a New Minimally Invasive Technique for the Extraperitoneal Repair of Incisional Hernias
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: Recurrent abdominal wall hernia
Incisional hernia
Lead sponsor: Gross Sand Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 615
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with symptomatic elective incisional hernias who were referred to Gross Sand Hernia Center of Reference

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients with symptomatic elective primary or secondary incisional hernias:
* Median incisional hernias
* Lateral incisional hernias

Exclusion Criteria:

* Emergencies
* Very large incisional hernias that required incisions larger than 12 cm

Primary outcomes:
measure: Recurrence after incisional hernia repair as assess by clinical examination at one year
timeFrame: one year follow-up
measure: Chronic pain after incisional hernia repair as reported by questionnaire and follow up examination at one year
timeFrame: one year follow-up
measure: Perioperative complications after incisional hernia repair
timeFrame: one year follow-up
measure: Reoperation after incisional hernia repair
timeFrame: one year follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Surgery and Hernia Center Gross Sand Hospital
name: Wolfgang Reinpold, Dr. MD
role: STUDY_DIRECTOR
References:
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.