Incisional HerniaMAGELANCT05528692
The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients
An observational study of Incisional Hernia and Emergency Midline Laparotomy, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Emergency Midline Laparotomy
- What is being tested?
- Magnetic resonance imaging (MRI)
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2025to Jun 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient operated with an emergency midline laparotomy in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the listed inclusion and exclusion criteria. We aim to enroll 100 patients to ensure that 50 patients fulfill the study protocol. This is based on a risk of incisional hernia development of at least 30% over two years among the included high-risk participants, a two-year mortality of the participants as a group of 30% and a 20% loss to follow-up amongst the survivors.
Who may be able to join
- Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding or any emergency re-operation to elective surgery
- Age of 18 years or above
- BMI above 27
- At least one risk factor for incisional hernia i.e. earlier midline laparotomy, BMI > 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age > 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone
Who cannot join
- Malign, incurable disease
- Other reasons for short life expectancy <2 year as evaluated by the investigator
- Midline-incisions <15 cm
- Mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall
- Severe claustrophobia or any other mental habitus, making it impossible to perform MRI-scan without sedation
- Metallic magnetic implants that serves as a contraindication for MRI-scan (including pacemakers, large tattoos, insulin pumps, etc.)
- Metallic prosthetic non-magnetic implants that are suspected to create severe artefacts on the MRI-scan of the abdominal wall
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gastrointestinal- and Hepatic diseases, Surgical Section,
Herlev, 2730
About this study
Official title: The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients: a Danish Prospective Single-center, Non-randomized, Non-interventional, Observational Study
The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.
Read the detailed description
All patients operated with an emergency midline laparotomy in our clinic are potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge.
Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates.
Enrolled patients will be followed for two years. The trial involves four consecutive MRI-scans one month, three months, six months and two years after surgery. Change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. A concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.
- Conditions
- Incisional Hernia, Emergency Midline Laparotomy
- Being tested
- Magnetic resonance imaging (MRI)
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Diagnostic test
MRI is a non-invasive imaging modality capable of producing precise soft-tissue images in all body areas. In contrast to CT scanning, MRI does not rely on ionizing radiation. There are no known risks associated with MRI as long as patients with contraindications such as pacemakers are identified and excluded. The MRI scans in this study will be performed without use of contrast media.
What is being measured
The primary outcome is the main question the study is designed to answer.
Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.
Measured: 2 years
Secondary outcomes (4)
MRI-diagnosed incisional hernia rates 3 months, 6 months and 2 years after laparotomy.
Measured: 2 years
Change in quality of life, physical functioning, clinical investigation and pain-score at 1 month, 3 months, 6 months and 2 years after laparotomy.
Measured: 2 years
Rate of MRI-verified subclinical vs. clinical detectable incisional hernias.
Measured: 2 years
30-day, 90-day, and 1-year mortality.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study startNov 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Why it stopped: Collaboration stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madeline Kvist, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528692
- Sponsor's protocol ID
- HerlevH2
- Acronym
- MAGELA
- Status last verified
- Nov 2024
- First submitted
- 2 Sep 2022
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All results, both positive, negative and inconclusive, will be attempted to be published in international English journals with external reviewers. Alternatively, the results will be published in another way.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time-Dependent Development of Incisional Hernias in Emergency Laparotomy Incisions of High-Risk Patients: a Danish Prospective Single-center, Non-randomized, Non-interventional, Observational Study
- ClinicalTrials.gov ID
- NCT05528692
- Acronym / sponsor ID
- MAGELA / HerlevH2
- Conditions
- Incisional Hernia, Emergency Midline Laparotomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Collaboration stopped
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Sep 2022 (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.
The aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive MRI-scans.
Detailed description
All patients operated with an emergency midline laparotomy in our clinic are potential participants and will be screened for participation. Potential participants will be briefly informed about the project by the hospital staff. If the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge.
Data will be obtained from the participants hospital files and by patient survey/interview. All data will be entered into a database using RedCap by trial investigators or their delegates.
Enrolled patients will be followed for two years. The trial involves four consecutive MRI-scans one month, three months, six months and two years after surgery. Change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. A concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient operated with an emergency midline laparotomy in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the listed inclusion and exclusion criteria. We aim to enroll 100 patients to ensure that 50 patients fulfill the study protocol. This is based on a risk of incisional hernia development of at least 30% over two years among the included high-risk participants, a two-year mortality of the participants as a group of 30% and a 20% loss to follow-up amongst the survivors.
Key inclusion criteria (4 listed)
- Unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and Crohn's disease), abscesses, non-traumatic intraabdominal bleeding or any emergency re-operation to elective surgery
- Age of 18 years or above
- BMI above 27
- At least one risk factor for incisional hernia i.e. earlier midline laparotomy, BMI > 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age > 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone
Key exclusion criteria (7 listed)
- Malign, incurable disease
- Other reasons for short life expectancy <2 year as evaluated by the investigator
- Midline-incisions <15 cm
- Mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall
- Severe claustrophobia or any other mental habitus, making it impossible to perform MRI-scan without sedation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance imaging (MRI)MRI is a non-invasive imaging modality capable of producing precise soft-tissue images in all body areas. In contrast to CT scanning, MRI does not rely on ionizing radiation. There are no known risks associated with MRI as long as patients with contraindications such as pacemakers are identified and excluded. The MRI scans in this study will be performed without use of contrast media. | Diagnostic test | – |
Primary outcome
Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy.
Time frame: 2 years
4 secondary outcomes
MRI-diagnosed incisional hernia rates 3 months, 6 months and 2 years after laparotomy.
Time frame: 2 years
Change in quality of life, physical functioning, clinical investigation and pain-score at 1 month, 3 months, 6 months and 2 years after laparotomy.
Time frame: 2 years
Rate of MRI-verified subclinical vs. clinical detectable incisional hernias.
Time frame: 2 years
30-day, 90-day, and 1-year mortality.
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: Yes. All results, both positive, negative and inconclusive, will be attempted to be published in international English journals with external reviewers. Alternatively, the results will be published in another way.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia and Emergency Midline Laparotomy, run by Herlev Hospital at 1 site in Denmark.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Early (30-days) MRI-diagnosed, incisional hernia development in high-risk patients after emergency midline laparotomy. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2025.