Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximati… (NCT04393532) | Clinical Trial Compass
CompletedNot Applicable
Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device
Israel, Slovenia29 participantsStarted 2020-02-23
Plain-language summary
Intended Use The Su2ura™ Approximation Device is indicated for tissue approximation in endoscopic and open surgery for the placement of interrupted or running stitches in soft tissue such as hernia repair
Objectives To assess the safety and efficacy of the Su2ura approximation device for the laparoscopic repair of primary umbilical hernia
Number of Subjects 45 patients
Number of Centers Two study centers in Israel and one in Slovenia.
Study Duration 6 months
Study Procedures 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.
Study follow up procedures:
Also include SAE's and SADE's during follow up
1. Quality of life questionnaire: patient-reported satisfaction and function will be assessed through the validated, hernia-specific European Hernia Society Quality of Life questionnaire (EuraHS-QoL)
2. Clinical testing to determine hernia recurrence and clinical bulging
Statistical analysis The sample size calculation based on the Exact Binomial distribution. The investigators will compute the 95% confidence intervals for a binomial probability, relying on the Clopper-Pearson (exact) method.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall rate of Serious Adverse Events and serious adverse device effects (SADE) up to hospital discharge and up to the 60th post-operative day.