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

Incisional Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133000
• Other study ID #: MILOS-Incisional-Hernia-2010
• Status: Completed
• Phase: N/A
• First received: April 17, 2017
• Last updated: April 25, 2017
• Start date: January 1, 2010
• Est. completion date: September 30, 2016

Study information

• Verified date: April 2017
• Source: Gross Sand Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 615
• Est. completion date: September 30, 2016
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gross Sand Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence after incisional hernia repair as assess by clinical examination at one year	Data collected in German National Hernia Registry (Herniamed)	one year follow-up
Primary	Chronic pain after incisional hernia repair as reported by questionnaire and follow up examination at one year	Data collected in German National Hernia Registry (Herniamed)	one year follow-up
Primary	Perioperative complications after incisional hernia repair	Data collected in German National Hernia Registry (Herniamed)	one year follow-up
Primary	Reoperation after incisional hernia repair	Data collected in German National Hernia Registry (Herniamed)	one year follow-up

External Links

•   Link