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:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT04393532
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Patient desires elective surgical repair
* Patient is able to give informed consent
* Diagnosis of a primary umbilical hernia with a fascial defect of width no more than 5 cm in size on clinical examination or CT scan
* Body mass index (BMI) 20-40 kg/m2
* Candidate for laparoscopic repair based on the operating surgeon's assessment
Exclusion Criteria:
* Non-primary or incisional hernia in the umbilical hernia
* Diagnosis of concomitant abdominal wall defect(s) contiguous with primary umbilical hernia
* Patient previously underwent open or laparoscopic umbilical hernia repair surgery
* Patient previously underwent open or laparoscopic abdominal surgery which spans the umbilical area
* Patient in need of concomitant non-hernia repair surgical procedure(s)
* Patient in need of emergent primary umbilical hernia repair for complications such as incarceration, intestinal obstruction or strangulation
* The patient desires hernia repair using a technique other than that consistent with the study
* Patient has loss of domain as assessed on physical examination or CT scan
* Patient has a severe co-morbid condition likely to limit survival to less than 2 years
* Patient was treated with chemotherapy in the past 6 months
* Patient was treated with steroids in the past 6 months
* Pre-operative or intra-operative contamination of the surgical site
* Patient with known collagen disorder
* Patient is pregnant or intends to become pregnant during the study period
* Patient has ascites on physical examination or CT scan
* Patient has cirrhosis
* Patient undergoing dialysis treatment
* Patient has a wound-healing disorder
* Patient has an untreated coagulation disorder or is on anti-coagulant therapy not managed peri-operatively with the advice or supervision of a hematologist
* Patient with autoimmune disorder requiring more than 10 mg of corticosteroid daily
* Patient who is immunocompromised (including a diagnosis of HIV/AIDS, organ transplant, or receiving chemo- or radiation therapy
* Non-compliance with the study protocol
* Patient requests to exist the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04393532
Study Brief:
Protocol Section:
NCT04393532