Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device
Primary Umbilical Hernia
About this trial
This is an interventional treatment trial for Primary Umbilical Hernia focused on measuring hernia, umbilical, repair, primary, laparoscopic
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
Sites / Locations
- Ziv Medical CenterRecruiting
- Barzilai Medical CenterRecruiting
- Splošna bolnišnica Izola (General Hospital Izola)
Arms of the Study
Arm 1
Experimental
Laparoscopic hernia repair using Su2ura Approximation Device
Surgery will be performed under general anesthesia. Standard antibiotic prophylaxis will be administered at induction of anesthesia. A single surgeon, the PI, will perform the procedure. A surgical assistant will be selected by the PI from the surgical staff of the department. The procedure will involve placement of laparoscopic ports, reduction of the hernia sac, closure of the defect with the Su2ura Approximation device and fixation of mesh with tacks over the closed defect. Study follow up visits: at post operation discharge, 14 days, 3 months, 6 months.