Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02816658 |
| Other study ID # |
15-1594 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2016 |
| Est. completion date |
June 2021 |
Study information
| Verified date |
January 2022 |
| Source |
The Cleveland Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
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.
