Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT03765060
Eligibility Criteria:
Inclusion Criteria:
1. Patients over 18 years of age and who provide informed consent to participate in the study.
2. Patients requiring an urgent midline laparotomy with a minimum size of 8 cm.
Exclusion Criteria:
1. Prior midline laparotomy.
2. Patients with BMI\> 45 kg / m2
3. Patients with ASA (American Society of Anesthesiologists)\> IV.
4. Patient with an advanced terminal illness with an expectation of life \<1 year.
5. Patients with abdominal aortic aneurysm.
6. Patients with coagulopathy: patient previously diagnosed with von Willebrand disease, hemophilia or Immune thrombocytopenic purpura.
7. Immunosuppressed patient: HIV patients in the AIDS phase, chronic corticosteroid or immunosuppressive treatment.
8. Patients with collagen pathology: patient previously diagnosed with Marfan syndrome, Ehlers-Danlos syndrome, homocystinuria and scleroderma.
9. Chemotherapeutic treatment 2 weeks before surgery.
10. Radiotherapy treatment 6 weeks before surgery.
11. Diffuse peritonitis with hemodynamic instability, defined by non-response to fluids prior to surgery or during the surgical process.
12. Pregnant or potentially fertile women, breastfeeding, or intention to become pregnant, or those who do not wish to use effective contraception (hormonal contraceptives (implantation, patches, oral), and double barrier methods (any double combination of: IUD (intrauterine device), male or female prophylactics with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03765060
Study Brief:
Protocol Section:
NCT03765060