The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

Sponsor
The Cleveland Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT02816658
Collaborator
(none)
102
6
2
61
17
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Laparoscopic Inguinal Hernia Repair
  • Other: Robotic Inguinal Hernia Repair
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Laparoscopic Surgery

Laparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach

Other: Laparoscopic Inguinal Hernia Repair
Laparoscopic Inguinal Hernia Repair

Active Comparator: Robotic Surgery

Robotic Inguinal Hernia Repair

Other: Robotic Inguinal Hernia Repair
Robotic Inguinal Hernia Repair

Outcome Measures

Primary Outcome Measures

  1. Pain Score [2 Years]

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

Secondary Outcome Measures

  1. Ergonomic Tool [2 Years]

    Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.

  2. Institution cost analysis [2 Years]

    Total cost of the operation for the two approaches.

  3. Long-term recurrence rate differences [2 Years]

    Comparison of recurrence rates, as assessed by an independed, blinded assessor

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University Saint Louis Missouri United States 63110
2 Mount Sinai Hospital New York New York United States 10028
3 New Hanover Regional Medical Center Wilmington North Carolina United States 28401
4 Cleveland Clinic Foundation Cleveland Ohio United States 44195
5 Greenville Health System Greenville South Carolina United States 29681
6 Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

  • Principal Investigator: Michael J Rosen, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Rosen, Director, Cleveland Clinic Comprehensive Hernia Center, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT02816658
Other Study ID Numbers:
  • 15-1594
First Posted:
Jun 28, 2016
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022