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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03133000

Enrollment

615

Registered

2017-04-28

Start date

2010-01-01

Completion date

2016-09-30

Last updated

2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

Keywords

Recurrent abdominal wall hernia, Incisional hernia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Recurrence after incisional hernia repair as assess by clinical examination at one year	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	one year follow-up	Data collected in German National Hernia Registry (Herniamed)
Perioperative complications after incisional hernia repair	one year follow-up	Data collected in German National Hernia Registry (Herniamed)
Reoperation after incisional hernia repair	one year follow-up	Data collected in German National Hernia Registry (Herniamed)

Outcome results