Laparoscopic Primary Umbilical Hernia Repair With Routine Defect Closure Using Su2ura Approximation Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Overall rate of Serious Adverse Events and serious adverse device effects (SADE) up to hospital discharge and up to the 60th post-operative day.
研究概览
简要总结
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
- 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)
- 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.
详细描述
DEVICE NAME AND INTENDED USE Device Name Su2ura™ Approximation Device
Intended Use The Su2ura™ Approximation Device ("Su2ura approximation device") is indicated for tissue approximation in endoscopic surgery for the placement of interrupted or running stitches in soft tissue such as hernia repair.
DEVICE DESCRIPTION Su2ura™ Approximation Device is a manual tissue approximation device comprised of an ergonomic Handle and Anchors threaded with suture.
Device Operation When using the Su2ura Approximation Device for suturing and approximation in MIS, the device is inserted through a 5mm port into the abdominal cavity and placed against the tissue. The surgeon presses the trigger to deploy threaded anchors into the tissue. Each anchor with a suture is placed with one single action. The surgeon may repeat the deployment operation several times at different target sites, as needed to form a short/long interrupted or running stitch. The device User Manual includes a recommendation to perform 4 continuous anchors each time whereas this process can be repeated again and again until the area is fully sutured. For approximation of the tissue after the anchors are positioned, the surgeon retracts the device from the port and ties an extracorporeal unidirectional surgical knot. The surgeon then changes the toggle into tightening mode and mounts the Cap on the shaft. The surgeon re-inserts the shaft through the port and slides the knot towards the approximation site using the tightening knob to collect thread and approximating the incision edges. The surgeon uses laparoscopic scissors to cut the thread and may repeat the suturing process again several times as needed until the incision is fully closed.
RISKS and BENEFITS The su2ura approximation device is designed according to international standards for medical devices. Compliance with these standards ensures that the device can be used safely in human beings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
single arm study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Overall rate of Serious Adverse Events and serious adverse device effects (SADE) up to hospital discharge and up to the 60th post-operative day.
时间窗: 60 days from baseline
AEs and SADEs will be documented and reviewed to assess the safety of the device
次要结局
- Patient satisfaction and function as assessed by the European Hernia Society quality of life questionnaire (EuraHS-QoL) at a 6-month follow up. Score range : 0-180, lower score indicates less pain and discomfort.(6 months)
- Evidence of seroma defined by clinical examination up to 6 months after surgery(6 months)
- Hernia Recurrence Rate at 6 months (Investigator confirmed hernia recurrence on physical examination)(6 months)
- Clinical bulging defined as any bulge of tissue or mesh beyond the natural contour of the abdomen on supine flexion at 6 months follow up.(6 months)