Incisional HerniaINCISENCT05509452
Risk Factors of Incisional Hernias After Emergency Midline Laparotomy
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 identify risk factors for the development of incisional hernias in emergency midline laparotomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Emergency Midline Laparotomy
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2026to Mar 2028
- How long will I take part?
- 2 Years
- 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 and followed up in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the inclusion and exclusion criteria listed above. We aim to include a total of 500 patients for the first follow-up. This is based on a drop out and long-term death of approximately 50%, incisional hernia rate of 20% and 10 risk factors in multivariate analysis requiring 100 patients with incisional hernias. 100 incisional hernias = 500 patients included at first post-operative follow up.
Who may be able to join
- Age of 18 years or above and
- 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 and any emergency re-operation to elective surgery
Who cannot join
- Age below 18 years
- Patients with mental or physical disorders making follow-up impossible
- Patients were no fascial closure is performed
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: Risk Factors of Incisional Hernias After Emergency Midline Laparotomy: a Danish Prospective Single-center, Non-randomized, Non-interventional, Descriptive Follow-up Study
The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.
Read the detailed description
All patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is 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 two clinical examinations and evaluations (one and two years) after surgery. Clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.
- Conditions
- Incisional Hernia, Emergency Midline Laparotomy
- Medical subject headings
- Incisional Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors of incisional hernia after emergency midline laparotomy
Multivariate analysis on selected variables evaluated for long-term complications, including sex, age, high BMI, active smoking, hernia in the midline, length of incision, rectus muscle diastasis, sarcopenia, peritonitis and multiple laparotomies
Measured: 2 years
Secondary outcomes (4)
Rate of incisional hernias one and two years after surgery
Measured: 2 years
30-day, 90-day, 1-year and 2-year mortality
Measured: 2 years
Rates of asymptomatic versus symptomatic incisional hernias
Measured: 2 years
Rate of surgery for incisional hernias 2-years post index surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study startJun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Why it stopped: Stopped before first enrollment due to no personnel resources and no funding
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)
- Target duration
- 2 Years
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
- NCT05509452
- Sponsor's protocol ID
- HerlevH1
- Acronym
- INCISE
- Status last verified
- May 2026
- First submitted
- 18 Aug 2022
- Last updated
- 15 May 2026
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Incisional Hernias After Emergency Midline Laparotomy: a Danish Prospective Single-center, Non-randomized, Non-interventional, Descriptive Follow-up Study
- ClinicalTrials.gov ID
- NCT05509452
- Acronym / sponsor ID
- INCISE / HerlevH1
- Conditions
- Incisional Hernia, Emergency Midline Laparotomy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Stopped before first enrollment due to no personnel resources and no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 22 Aug 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 identify risk factors for the development of incisional hernias in emergency midline laparotomies.
Detailed description
All patients operated with an emergency midline laparotomy and attending 1-year follow-up in our clinic is 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 two clinical examinations and evaluations (one and two years) after surgery. Clinical examination involves interview with a standardized questionnaire and abdominal wall examination including inspection, palpation and ultrasound examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
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 and followed up in our clinic will be evaluated for enrollment. Patients will be eligible if they comply with the inclusion and exclusion criteria listed above. We aim to include a total of 500 patients for the first follow-up. This is based on a drop out and long-term death of approximately 50%, incisional hernia rate of 20% and 10 risk factors in multivariate analysis requiring 100 patients with incisional hernias. 100 incisional hernias = 500 patients included at first post-operative follow up.
Key inclusion criteria (2 listed)
- Age of 18 years or above and
- 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 and any emergency re-operation to elective surgery
Key exclusion criteria (3 listed)
- Age below 18 years
- Patients with mental or physical disorders making follow-up impossible
- Patients were no fascial closure is performed
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
Risk factors of incisional hernia after emergency midline laparotomy
Time frame: 2 years
Multivariate analysis on selected variables evaluated for long-term complications, including sex, age, high BMI, active smoking, hernia in the midline, length of incision, rectus muscle diastasis, sarcopenia, peritonitis and multiple laparotomies
4 secondary outcomes
Rate of incisional hernias one and two years after surgery
Time frame: 2 years
30-day, 90-day, 1-year and 2-year mortality
Time frame: 2 years
Rates of asymptomatic versus symptomatic incisional hernias
Time frame: 2 years
Rate of surgery for incisional hernias 2-years post index surgery
Time frame: 2 years
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 15 May 2026.
- 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 2 inclusion and 3 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 15 May 2026. 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?
Risk factors of incisional hernia 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 15 May 2026.