Hernia, InguinalNCT02816658
The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
A study testing Laparoscopic Inguinal Hernia Repair and Robotic Inguinal Hernia Repair in people with Hernia, Inguinal, run by The Cleveland Clinic at 6 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Laparoscopic Inguinal Hernia Repair and Robotic Inguinal Hernia Repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2016to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Greenville Health System
Greenville, South Carolina, 29681
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mount Sinai Hospital
New York, New York, 10028
Washington University
St Louis, Missouri, 63110
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Hernia, Inguinal
- Being tested
- Laparoscopic Inguinal Hernia Repair, Robotic Inguinal Hernia Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Inguinal Hernia RepairOther
Laparoscopic Inguinal Hernia Repair
Robotic Inguinal Hernia RepairOther
Robotic Inguinal Hernia Repair
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Surgery | Active comparator | Laparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach Receives: Other: Laparoscopic Inguinal Hernia Repair |
| Robotic Surgery | Active comparator | Robotic Inguinal Hernia Repair Receives: Other: Robotic Inguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Differences in postoperative pain between those patients who undergo robotic inguinal hernia repair versus laparoscopic inguinal hernia repair.
Measured: 2 Years
Secondary outcomes (3)
Ergonomic Tool
Differences in surgeon ergonomics between the two approaches as measured by the NASA-TLX and RULA ergonomic assessments.
Measured: 2 Years
Institution cost analysis
Total cost of the operation for the two approaches.
Measured: 2 Years
Long-term recurrence rate differences
Comparison of recurrence rates, as assessed by an independed, blinded assessor
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Rosen, The Cleveland Clinic
- Investigators
- Michael J Rosen, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816658
- Sponsor's protocol ID
- 15-1594
- Status last verified
- Jan 2022
- First submitted
- 26 May 2016
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32186683
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Robotic Platform in Inguinal Hernia Repair Surgery
- ClinicalTrials.gov ID
- NCT02816658
- Acronym / sponsor ID
- 15-1594
- Conditions
- Hernia, Inguinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Surgery | Active comparator | Other: Laparoscopic Inguinal Hernia RepairLaparoscopic Inguinal Hernia Repair through a Transabdominal, Preperitoneal Approach |
| Robotic Surgery | Active comparator | Other: Robotic Inguinal Hernia RepairRobotic Inguinal Hernia Repair |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Inguinal Hernia RepairLaparoscopic Inguinal Hernia Repair | Other | Laparoscopic Surgery |
| Robotic Inguinal Hernia RepairRobotic Inguinal Hernia Repair | Other | Robotic Surgery |
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.
3 secondary outcomes
Ergonomic Tool
Time frame: 2 Years
Institution cost analysis
Time frame: 2 Years
Long-term recurrence rate differences
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 32186683Prabhu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Rosen, MD principal investigator
The Cleveland Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Inguinal Hernia Repair and Robotic Inguinal Hernia Repair in people with Hernia, Inguinal, run by The Cleveland Clinic at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02816658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.