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

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.

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Key information

Conditions

Incisional Hernia Hernia Hernia, Abdominal Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Gross Sand Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2016
First posted: Apr 28, 2017
Registry last updated: Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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