Hernia, InguinalNCT04353687
Early Surgeon Experience With Robotic-Assisted Inguinal Hernia Repair
An observational study of Hernia, Inguinal, run by Intuitive Surgical at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Robotic-assisted inguinal hernia repair
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2020to 30 Jun 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended study population will be compromised of general surgeons. All surgeons will be qualified general surgeons by training and experienced in performing open or laparoscopic inguinal hernia repair and will be transitioning to robotic-assisted inguinal hernia repair. All surgeons will have zero or minimal experience with robotic-assisted inguinal hernia repair.
Who may be able to join
- Signed and dated informed consent by adult surgeon subject
- Practicing general surgeon with no or limited robotic assisted experience
- Full access to the da Vinci surgical system at hospital and ability to perform robotic cases as needed
- Willingness to participate in all aspects of the study
Who cannot join
- 1. Condition(s) that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PROGRESS: A PROspective Evaluation of the Early surGeon expeRiencE With Robotic-aSSisted (RA) Inguinal Hernia Repair (IHR)
The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve.
Read the detailed description
This is a prospective, multi-center, observational pilot study evaluating surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair. The study will focus on surgeon intraoperative efficiency and technical performance outcomes as well as conversions, intraoperative complications, and mental and cognitive workload. Surgeon subjects will be assessed for technical proficiency through a study specific technical proficiency form and the GEARS scale by independent surgeons.
- Conditions
- Hernia, Inguinal
- Being tested
- Robotic-assisted 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.
Robotic-assisted inguinal hernia repairDevice
Each surgeon will perform the robotic-assisted inguinal hernia procedure per their standard practice. Surgeon subjects will consent to prospectively provide selected procedure and case data.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Open Surgeons | Primarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience. Receives: Device: Robotic-assisted inguinal hernia repair | |
| Cohort 2 Laparoscopic Surgeons | Primarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience. Receives: Device: Robotic-assisted inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of surgeon efficiency
Change of skin to skin procedure time, dissection time, time to establish critical view of the myopectineal orifice (MPO), and mesh fixation time through the assessment of intraoperative tasks
Measured: Assessed intraoperatively (all cases)
Change of surgeon proficiency/performance
Change of technical proficiency scores and Global Evaluative Assessment of Robotic Skills (GEARS) scores cases as assessed by independent video review.
Measured: Within one month following surgery (every 12th case ± 2 cases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start17 Mar 2020
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353687
- Sponsor's protocol ID
- ISI-HLC-2019
- Status last verified
- Mar 2024
- First submitted
- 9 Apr 2020
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGRESS: A PROspective Evaluation of the Early surGeon expeRiencE With Robotic-aSSisted (RA) Inguinal Hernia Repair (IHR)
- ClinicalTrials.gov ID
- NCT04353687
- Acronym / sponsor ID
- ISI-HLC-2019
- Conditions
- Hernia, Inguinal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 20 Apr 2020 (actual)
- 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.
The primary objective of this study is to evaluate the progression of surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair throughout their learning curve.
Detailed description
This is a prospective, multi-center, observational pilot study evaluating surgeon efficiency and proficiency of traditionally open or laparoscopic surgeons performing robotic-assisted inguinal hernia repair. The study will focus on surgeon intraoperative efficiency and technical performance outcomes as well as conversions, intraoperative complications, and mental and cognitive workload. Surgeon subjects will be assessed for technical proficiency through a study specific technical proficiency form and the GEARS scale by independent surgeons.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Open Surgeons | – | Device: Robotic-assisted inguinal hernia repairPrimarily open inguinal hernia surgeon with no or limited previous robotic-assisted experience. |
| Cohort 2 Laparoscopic Surgeons | – | Device: Robotic-assisted inguinal hernia repairPrimarily laparoscopic inguinal hernia surgeon with no or limited previous robotic-assisted experience. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The intended study population will be compromised of general surgeons. All surgeons will be qualified general surgeons by training and experienced in performing open or laparoscopic inguinal hernia repair and will be transitioning to robotic-assisted inguinal hernia repair. All surgeons will have zero or minimal experience with robotic-assisted inguinal hernia repair.
Key inclusion criteria (4 listed)
- Signed and dated informed consent by adult surgeon subject
- Practicing general surgeon with no or limited robotic assisted experience
- Full access to the da Vinci surgical system at hospital and ability to perform robotic cases as needed
- Willingness to participate in all aspects of the study
Key exclusion criteria (1 listed)
- 1. Condition(s) that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
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 |
|---|---|---|
| Robotic-assisted inguinal hernia repairEach surgeon will perform the robotic-assisted inguinal hernia procedure per their standard practice. Surgeon subjects will consent to prospectively provide selected procedure and case data. | Device | Cohort 1 Open Surgeons, Cohort 2 Laparoscopic Surgeons |
Primary outcome
Change of surgeon efficiency
Time frame: Assessed intraoperatively (all cases)
Change of skin to skin procedure time, dissection time, time to establish critical view of the myopectineal orifice (MPO), and mesh fixation time through the assessment of intraoperative tasks
Change of surgeon proficiency/performance
Time frame: Within one month following surgery (every 12th case ± 2 cases)
Change of technical proficiency scores and Global Evaluative Assessment of Robotic Skills (GEARS) scores cases as assessed by independent video review.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal, run by Intuitive Surgical at 1 site 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Change of surgeon efficiency (time frame: Assessed intraoperatively (all cases)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2024.