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

NCT03133000 | Completed DMC

• 1 other identifier: MILOS-Incisional-Hernia-2010
• Study Type: observational
• Target: 615
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Incisional Hernia

Keywords

Recurrent abdominal wall hernia; Incisional hernia

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Perioperative complications after incisional hernia repair

  Data collected in German National Hernia Registry (Herniamed)

  one year follow-up

• Reoperation after incisional hernia repair

  Data collected in German National Hernia Registry (Herniamed)

  one year follow-up

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients with symptomatic elective primary or secondary incisional hernias:
• Median incisional hernias
• Lateral incisional hernias

You may not qualify if:

• Emergencies
• Very large incisional hernias that required incisions larger than 12 cm

Sponsors & Collaborators

• Gross Sand Hospital: lead

Related Publications (2)

• 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.

  PMID: 37603090 DERIVED

• 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.

  PMID: 29342018 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Incisional Hernia; Hernia, Abdominal

Condition Hierarchy (Ancestors)

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

Study Officials

• Wolfgang Reinpold, Dr. MD

  Department of Surgery and Hernia Center Gross Sand Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Surgery and Hernia Center Gross Sand Hospital

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 28, 2017
• Study Start: January 1, 2010
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share