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

NCT ID: NCT03133000

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

615 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2016-09-30

Brief Summary

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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

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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.

Conditions

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Incisional Hernia

Keywords

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Recurrent abdominal wall hernia Incisional hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gross Sand Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wolfgang Reinpold

Director of the Department of Surgery and Hernia Center Gross Sand Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wolfgang Reinpold, Dr. MD

Role: STUDY_DIRECTOR

Department of Surgery and Hernia Center Gross Sand Hospital

References

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Reinpold W, Berger C, Adolf D, Kockerling F. Mini- or less-open sublay (E/MILOS) operation vs open sublay and laparoscopic IPOM repair for the treatment of incisional hernias: a registry-based propensity score matched analysis of the 5-year results. Hernia. 2024 Feb;28(1):179-190. doi: 10.1007/s10029-023-02847-3. Epub 2023 Aug 21.

Reference Type DERIVED
PMID: 37603090 (View on PubMed)

Reinpold W, Schroder M, Berger C, Nehls J, Schroder A, Hukauf M, Kockerling F, Bittner R. Mini- or Less-open Sublay Operation (MILOS): A New Minimally Invasive Technique for the Extraperitoneal Mesh Repair of Incisional Hernias. Ann Surg. 2019 Apr;269(4):748-755. doi: 10.1097/SLA.0000000000002661.

Reference Type DERIVED
PMID: 29342018 (View on PubMed)

Related Links

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Other Identifiers

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MILOS-Incisional-Hernia-2010

Identifier Type: -

Identifier Source: org_study_id