Clinical Trial: The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

Brief Summary:

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.


Detailed Summary:

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
Sponsor: The Cleveland Clinic

Current Primary Outcome: Pain Score [ Time Frame: 2 Years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ergonomic Tool [ Time Frame: 2 Years ]
    Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.
  • Institution cost analysis [ Time Frame: 2 Years ]
    Total cost of the operation for the two approaches.
  • Long-term recurrence rate differences [ Time Frame: 2 Years ]
    Comparison of recurrence rates, as assessed by an independed, blinded assessor


Original Secondary Outcome:

  • Ergonomic Tool [ Time Frame: 2 Years ]
    Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.
  • Institution cost analysis [ Time Frame: 2 Years ]
    Total cost of the operation for the two approaches.
  • Long-term recurrence rate differences [ Time Frame: 2 Years ]


Information By: The Cleveland Clinic

Dates:
Date Received: May 26, 2016
Date Started: May 2016
Date Completion: May 2019
Last Updated: May 17, 2017
Last Verified: May 2017