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临床试验/NCT02816658
NCT02816658已完成不适用

The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

The Cleveland Clinic12 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
12
主要终点
Pain Score

研究概览

简要总结

Inguinal hernia repair is one of the most commonly performed general surgery operations. However, to date, the ideal surgical approach for inguinal hernia surgery. The investigators therefore, propose a randomized controlled trial comparing laparoscopic inguinal hernia surgery repair to robotic inguinal hernia repair surgery.

The investigators hypothesize that the robotic approach to inguinal hernia repair will result in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia repairs.

Specific Aim #1: To determine if the robotic approach will result in a significant reduction in postoperative pain and earlier return to full function when compared to a laparoscopic inguinal hernia repair.

Specific Aim #2: To perform a cost analysis to determine the financial implications of performing a robotic versus a laparoscopic inguinal hernia repair.

Specific Aim #3: To determine the effect of surgeon reported ergonomics when performing laparoscopic versus robotic inguinal hernia repairs.

Specific Aim #4: Evaluate the long term hernia recurrence rates associated with laparoscopic versus robotic inguinal hernia repairs.

详细描述

Inguinal hernia repair is the most commonly performed general surgery procedure in the United States. Despite the prevalence of this procedure, there is no consensus regarding the optimal approach to this surgical procedure. Since the advent of the laparoscopic inguinal hernia repair in 1990, there is a growing body of research that has investigated the efficacy of this minimally invasive surgical approach. To date, the laparoscopic approach to inguinal hernia repair has proven beneficial in reducing post-operative pain and allowing for earlier return to normal activity versus the traditional open inguinal hernia repair. In addition, the laparoscopic approach to inguinal hernia repair has been advocated for recurrent inguinal hernia repairs and bilateral inguinal hernia repairs.

Despite these advantages, however, there are several limitations of the laparoscopic inguinal hernia repair. Specifically, unstable camera platforms, two-dimensional imaging, rigid laparoscopic instruments, and poor surgeon ergonomics make the laparoscopic approach to inguinal hernia repair challenging. Furthermore, the learning curve associated with a laparoscopic inguinal hernia repair has been prohibitive for many surgeons. Finally, the laparoscopic approach to inguinal hernia repair often requires the utilization of some form of fixation device, such as surgical tacks, which have been associated with chronic pain, vascular injury, as well as increased overall cost of the operation. The robotic platform has been shown to help compensate for many of these short-comings of laparoscopic surgery as it provides three-dimensional imaging, improved instrument mobility, articulation, suturing capability (which allows for a more cost-effective procedure with decreased risk of post-operative chronic pain), and surgeon comfort. Because of these reasons, it is important to determine the specific advantages the robotic approach will provide for inguinal hernia repairs.

The laparoscopic approach to inguinal hernia repair has proven beneficial in reducing post-operative pain and earlier returns to normal activity versus the traditional open inguinal hernia repair. However, the overall penetrance of laparoscopic inguinal hernia repair has remained consistently below 20% of all inguinal hernia procedures performed in the United States. The robotic platform provides several potential advantages over the laparoscopic inguinal hernia repair including three dimensional visualization, the ability to suture (rather than tack) the mesh, as well as the ability to suture the peritoneal defect closed. This technological platform could provide earlier adoption and proficiency for surgeons to perform a minimally invasive inguinal hernia repair with improved surgical outcomes. As more general surgeons begin to incorporate robotic surgery into their practice, the robotic platform might provide further improvements in the outcomes of minimally invasive inguinal hernia repair over even traditional laparoscopic inguinal hernia repair.

The investigators propose a Randomized Clinical Trial comparing the robotic versus laparoscopic inguinal hernia repair techniques. The investigators hypothesize that the robotic approach to inguinal hernia repair will result in improved post-operative outcomes compared to traditional laparoscopic inguinal hernia repairs.

Specific Aim #1: To determine if the robotic approach will result in a significant reduction in postoperative pain and earlier return to full function when compared to a laparoscopic inguinal hernia repair.

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)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21 years or older
  • No prior open abdominal surgery at or below the umbilicus
  • Primary or recurrent unilateral inguinal hernia repair
  • No previous preperitoneal mesh placement
  • BMI less than or equal to 40kg/m2

排除标准

  • Need for an open inguinal hernia repair
  • Patients presenting for evaluation of bilateral inguinal hernias
  • Patients requiring surgical repair of a strangulated inguinal hernia
  • Patients with liver disease defined by the presence of ascites
  • Patients with end-stage renal disease requiring dialysis
  • Patients who are unable to give informed consent.

结局指标

主要结局

Pain Score

时间窗: 2 Years

Differences in postoperative pain between those patients who undergo robotic inguinal hernia repair versus laparoscopic inguinal hernia repair.

次要结局

  • Ergonomic Tool(2 Years)
  • Institution cost analysis(2 Years)
  • Long-term recurrence rate differences(2 Years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Rosen

Director, Cleveland Clinic Comprehensive Hernia Center

The Cleveland Clinic

研究点 (12)

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