Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stopped before first enrollment due to no personnel resources and no funding
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to identify risk factors for the development of incisional hernias in emergency midline laparotomies.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of incisional hernias one and two years after surgery | 2 years | |
| 30-day, 90-day, 1-year and 2-year mortality | 2 years | |
| Rates of asymptomatic versus symptomatic incisional hernias |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal- and Hepatic diseases, Surgical Section, | Herlev | 2730 | Denmark |
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.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
| 2 years |
| Rate of surgery for incisional hernias 2-years post index surgery | 2 years |
| D010335 | Pathologic Processes |