A Multi-center, Randomized, Controlled, Single Blinded, Parallel-group Study Evaluating the Clinical Performance and Safety of LiquiBand FIX8® Versus Control for Hernia Mesh Fixation and Peritoneal Closure in Groin Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 12
- 主要终点
- Change in Pain
研究概览
简要总结
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Randomization to either Investigational or control device will occur at the surgery visit. The patients will be blinded to their randomly assigned treatment device prior to surgery and during the follow up period following surgery. While it is not possible to blind investigators/staff members to the treatment device used, Investigators and staff members will not learn of randomized device until immediately prior to use of device, so as to maintain subject blinding prior to the hernia repair. Investigators and staff members will be asked to maintain subject blinding through the course of the follow up visits so as to not bias subject feedback on applicable study assessments. Patients will receive the same standard of care prior to, during and following surgery regardless of randomized device assignment, and therefore will not be able to individually determine what device they have been randomized to.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is male or female, ≥22 years of age
- •Is willing and able to give written informed consent
- •Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral)
- •Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or femoral)
- •Hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the following;
- •3D Max™ Mesh (Bard Inc.)
- •3D Max™ Light (Bard Inc.)
- •Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic)
- •Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic)
- •Is willing and able to comply with the protocol assessments at time of surgery and during the post surgical follow up period
排除标准
- •Has a hernia type not suitable for laparoscopic hernia repair as determined by the Investigator (i.e. strangulated)
- •Subject has a recurrent groin hernia previously repaired laparoscopically, has an anatomical defect or had prior surgical procedures that in the opinion of the Investigator prevents access to the pre-peritoneal space for TAPP or TEP laparoscopic hernia repair
- •Is pregnant or actively breastfeeding
- •Has a known sensitivity to cyanoacrylate or formaldehyde,D&C Violet No.2 dye or any component of LiquiBand FIX8® or control device
- •Has an active or potential infection at the surgical site or systemic sepsis
- •Hernia mesh to be used at surgery is less than 4"x6" in size, or not one of the types of mesh listed in Inclusion Criteria above
- •Cannot tolerate general anaesthesia
- •Has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with his/her ability to participate in the study
结局指标
主要结局
Change in Pain
时间窗: Assessed at pre-surgery (baseline), day 7, day 14, month 1, month 3 and month 6 post surgery. Change from baseline at month 6 reported.
Change in pain from baseline to 6 month will be assessed and compared to treatment with AbsorbaTack™ in subjects requiring laparoscopic (TEP and TAPP) hernia repair where the VAS value is 0 - 10, 0 = no pain and 10 = worst pain imaginable.
次要结局
- Incidence of Successful Peritoneal Closure (TAPP Repairs Only)(Time of surgery.)
- Successful Mesh Fixation at the Time of Surgery.(Time of surgery.)
- Levels of Pain Experienced as Measured by Visual Analogue Scale (VAS).(Evaluation of pain will be measured at pre-surgery, discharge (up to 3 days), Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery)
- Quality of Life as Measured by the Carolinas Comfort Scale (CCS).(Pre-Surgery, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery)
- Number of Participants With Hernia Recurrence(Assessed at week 2, month 3, month 6 and month 12 post surgery. Month 12 post surgery reported)
- Safety as Measured by the Incidence of Adverse Events.(Intraoperatively, Discharge, Week 1, Week 2, Month 1, Month 3, Month 6, Month 9 and Month 12 post surgery)