Incisional HerniaNCT03133000
Mini- or Less-Open Sublay Operation (MILOS) of Incisional Hernias
An observational study of Incisional Hernia, run by Gross Sand Hospital.
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Incisional Hernia
- How many people
- 615 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Sep 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with symptomatic elective incisional hernias who were referred to Gross Sand Hernia Center of Reference
Who may be able to join
- All patients with symptomatic elective primary or secondary incisional hernias:
- Median incisional hernias
- Lateral incisional hernias
Who cannot join
- Emergencies
- Very large incisional hernias that required incisions larger than 12 cm
About this study
Official title: 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.
Read the 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.
- Conditions
- Incisional Hernia
- Keywords
- Recurrent abdominal wall hernia, Incisional hernia
- Medical subject headings
- Incisional Hernia, Hernia, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence after incisional hernia repair as assess by clinical examination at one year
Data collected in German National Hernia Registry (Herniamed)
Measured: 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)
Measured: one year follow-up
Perioperative complications after incisional hernia repair
Data collected in German National Hernia Registry (Herniamed)
Measured: one year follow-up
Reoperation after incisional hernia repair
Data collected in German National Hernia Registry (Herniamed)
Measured: one year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Jan 2010
- Primary completion30 Sep 2015
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 615 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gross Sand Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Reinpold, Gross Sand Hospital
- Investigators
- Wolfgang Reinpold, Dr. MD, Study director, Department of Surgery and Hernia Center Gross Sand Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133000
- Sponsor's protocol ID
- MILOS-Incisional-Hernia-2010
- Status last verified
- Apr 2017
- First submitted
- 17 Apr 2017
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37603090Reinpold 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.
PubMed 29342018
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini- or Less-Open Sublay Operation (MILOS) - a New Minimally Invasive Technique for the Extraperitoneal Repair of Incisional Hernias
- ClinicalTrials.gov ID
- NCT03133000
- Acronym / sponsor ID
- MILOS-Incisional-Hernia-2010
- Conditions
- Incisional Hernia
- Keywords
- Recurrent abdominal wall hernia, Incisional hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- Gross Sand HospitalUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with symptomatic elective incisional hernias who were referred to Gross Sand Hernia Center of Reference
Key inclusion criteria (3 listed)
- All patients with symptomatic elective primary or secondary incisional hernias:
- Median incisional hernias
- Lateral incisional hernias
Key exclusion criteria (2 listed)
- Emergencies
- Very large incisional hernias that required incisions larger than 12 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Perioperative complications after incisional hernia repair
Time frame: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
Reoperation after incisional hernia repair
Time frame: one year follow-up
Data collected in German National Hernia Registry (Herniamed)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 37603090Reinpold 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.
- Derived from this study: PubMed 29342018Reinpold 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Reinpold, Dr. MD study director
Department of Surgery and Hernia Center Gross Sand Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Gross Sand Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence after incisional hernia repair as assess by clinical examination at one year (time frame: one year follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133000, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.