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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03133000
Other study ID # MILOS-Incisional-Hernia-2010
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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