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

April 25, 2017 updated by: Wolfgang Reinpold, Gross Sand Hospital

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with symptomatic elective incisional hernias who were referred to Gross Sand Hernia Center of Reference

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one year follow-up
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)
one year follow-up
Perioperative complications after incisional hernia repair
Time Frame: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
one year follow-up
Reoperation after incisional hernia repair
Time Frame: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
one year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gross Sand Hospital

Investigators

  • Study Director: Wolfgang Reinpold, Dr. MD, Department of Surgery and Hernia Center Gross Sand Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

September 30, 2015

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MILOS-Incisional-Hernia-2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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