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The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic Inguinal Hernia Repair
Robotic Inguinal Hernia Repair
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Washington University
  • Mount Sinai Hospital
  • New Hanover Regional Medical Center
  • Cleveland Clinic Foundation
  • Greenville Health System
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Laparoscopic Surgery

Robotic Surgery

Arm Description

Laparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach

Robotic Inguinal Hernia Repair

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2016
Last Updated
January 28, 2022
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02816658
Brief Title
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
Official Title
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2021 (Actual)
Study Completion Date
June 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laparoscopic Surgery
Arm Type
Active Comparator
Arm Description
Laparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach
Arm Title
Robotic Surgery
Arm Type
Active Comparator
Arm Description
Robotic Inguinal Hernia Repair
Intervention Type
Other
Intervention Name(s)
Laparoscopic Inguinal Hernia Repair
Intervention Description
Laparoscopic Inguinal Hernia Repair
Intervention Type
Other
Intervention Name(s)
Robotic Inguinal Hernia Repair
Intervention Description
Robotic Inguinal Hernia Repair
Primary Outcome Measure Information:
Title
Pain Score
Description
Differences in postoperative pain between those patients who undergo robotic inguinal hernia repair versus laparoscopic inguinal hernia repair.
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Ergonomic Tool
Description
Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.
Time Frame
2 Years
Title
Institution cost analysis
Description
Total cost of the operation for the two approaches.
Time Frame
2 Years
Title
Long-term recurrence rate differences
Description
Comparison of recurrence rates, as assessed by an independed, blinded assessor
Time Frame
2 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Rosen, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32186683
Citation
Prabhu AS, Carbonell A, Hope W, Warren J, Higgins R, Jacob B, Blatnik J, Haskins I, Alkhatib H, Tastaldi L, Fafaj A, Tu C, Rosen MJ. Robotic Inguinal vs Transabdominal Laparoscopic Inguinal Hernia Repair: The RIVAL Randomized Clinical Trial. JAMA Surg. 2020 May 1;155(5):380-387. doi: 10.1001/jamasurg.2020.0034.
Results Reference
derived

Learn more about this trial

The Role of the Robotic Platform in Inguinal Hernia Repair Surgery

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