The Role of the Robotic Platform in Inguinal Hernia Repair Surgery



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:21 - Any
Updated:6/15/2018
Start Date:May 2016
End Date:May 2019
Contact:Michael J Rosen, MD, FACS
Email:rosenm@ccf.org
Phone:216-445-3441

Use our guide to learn which trials are right for you!

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.

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.

Inclusion Criteria:

1. 21 years or older

2. No prior open abdominal surgery at or below the umbilicus

3. Primary or recurrent unilateral inguinal hernia repair

4. No previous preperitoneal mesh placement

5. BMI less than or equal to 40kg/m2

Exclusion Criteria:

1. Need for an open inguinal hernia repair

2. Patients presenting for evaluation of bilateral inguinal hernias

3. Patients requiring surgical repair of a strangulated inguinal hernia

4. Patients with liver disease defined by the presence of ascites

5. Patients with end-stage renal disease requiring dialysis

6. Patients who are unable to give informed consent.
We found this trial at
6
sites
New York, New York 10029
Phone: 212-379-6677
?
mi
from
New York, NY
Click here to add this to my saved trials
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-445-3441
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Greenville, South Carolina 29615
Phone: 864-455-5795
?
mi
from
Greenville, SC
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-955-5240
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Saint Louis, Missouri 63110
Phone: 314-454-7195
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials