Hernia, InguinalNCT02684448
Evaluation of Clinical Outcomes in Robotic-Assisted Inguinal Hernia Repair
An observational study of Hernia, Inguinal and Hernia, Inguinal, Direct, run by Intuitive Surgical at 2 sites in United States.
Trial summary
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as provide information about the learning curve associated with robotic-assisted (da Vinci®)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Hernia, Inguinal, Direct, Hernia, Inguinal, Indirect
- What is being tested?
- Inguinal Hernia Repair
- Type of treatment
- Surgery or procedure
- How many people
- 1,258 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Jan 2017
- 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: All subjects who have undergone robotic-assisted inguinal hernia repair or open hernia repair per specified time frame described in inclusion/exclusion criteria
Who may be able to join
- all patients who have undergone inguinal hernia repair using either an open technique or a robotic-assisted (da Vinci®) approach
- Eligible subjects must have had their inguinal hernia repair completed according to the following timeframes for inclusion:
- Robotic-assisted (da Vinci®) hernia repair - all consecutive robotic cases from the initiation of robotic -assisted inguinal hernia repair at each institution until 30 days prior to the date of study initiation (IRB approval and fully executed contract).
- Open hernia repair - all consecutive open hernia repair cases from the day prior to the 1st da Vinci® inguinal hernia repair until the number of open repair cases collected is equivalent to the number of da Vinci® cases entered, or the date 5 years pre-robotic initiation is reached.
Who cannot join
- Subjects who have undergone robotic-assisted or open inguinal hernia repair outside of required timeframe
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Progressive Surgical Associates/Silver Cross Hospital
New Lenox, Illinois, 60451
Rochester General Hospital
Rochester, New York, 14621
About this study
Official title: A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes in Inguinal Hernia Repair
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as provide information about the learning curve associated with robotic-assisted (da Vinci®) inguinal hernia repair.
In addition, this retrospective data collection study will evaluate the perioperative outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative outcomes with those associated with open hernia repair by the same participating surgeon.
Read the detailed description
This study is a retrospective data collection from existing medical records, is observational in nature and is designed to evaluate feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone inguinal hernia repair surgery during the time period from initiation of robotic-assisted surgery to 30 days prior to study initiation (IRB approval and fully executed data collection agreement) for approximately 500 subjects. Any inguinal hernia repair procedure that uses the da Vinci® surgical system at any point will be collected.
This data will be compared with data associated with open inguinal hernia repairs performed by the same surgeons from a period of 5 years prior to the initiation of robotic surgery at each participating institution until 30 days prior to study initiation. Sites will collect data from consecutive open inguinal hernia repair cases starting with the day prior to the 1st robotic-assisted inguinal hernia repair, and continue collecting data until the number of open inguinal hernia repair cases is equivalent to the number of robotic-assisted inguinal hernia repair cases, or until the open repair procedure date reaches 5 years prior to the 1st robotic-assisted inguinal hernia repair case.
Data collected will include, but is not limited to, the following:
- Demographics and baseline/pre-operative clinical parameters: Gender, age, BMI, comorbidities, smoking history, prior hernia history, prior abdominal surgery history, hernia description
- Intraoperative parameters: procedure details related to repair, operative time, conversions to open, blood loss, intraoperative complications
- Post-operative through discharge : length of hospital stay, post-operative complications
- Post-operative information regarding complications, readmissions and reoperations through 30 days post-discharge.
- Hernia Recurrence, if available
The total duration for this study will be approximately 12 months
- Being tested
- 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.
Inguinal Hernia RepairProcedure or surgery
Also called Herniorrhaphy
Inguinal (unilateral or bilateral) hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Robotic-Assisted Inguinal Hernia Repair | Subjects who have undergone robotic-assisted (da Vinci) inguinal hernia repair from the initiation of robotic-assisted hernia repair at site through December 2015. Receives: Procedure: Inguinal Hernia Repair | |
| Open Inguinal Hernia Repair | Subjects who have undergone open inguinal hernia repair from the day prior to initiation of robotic-assisted hernia repair through 5 years prior to initiation. Receives: Procedure: Inguinal Hernia Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications observed intraoperatively through 30-days
Measured: Intraoperative through 30-days follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJan 2017
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 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
- Retrospective
- Enrolment
- 1,258 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
- NCT02684448
- Sponsor's protocol ID
- ISI-IHR-2015-001
- Status last verified
- Mar 2017
- First submitted
- 12 Feb 2016
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Dickens EO, Kolachalam R, Gonzalez A, Richardson C, D'Amico L, Rabaza J, Gamagami R. Does robotic-assisted transabdominal preperitoneal (R-TAPP) hernia repair facilitate contralateral investigation and repair without compromising patient morbidity? J Robot Surg. 2018 Dec;12(4):713-718. doi: 10.1007/s11701-018-0815-4. Epub 2018 Apr 30.
PubMed 29713930
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Multi-Center Study for Evaluation of Clinical Outcomes in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02684448
- Acronym / sponsor ID
- ISI-IHR-2015-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,258 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 18 Feb 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.
This multi-center, retrospective data collection study will evaluate the feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone robotic-assisted inguinal hernia repair, as well as provide information about the learning curve associated with robotic-assisted (da Vinci®) inguinal hernia repair.
In addition, this retrospective data collection study will evaluate the perioperative outcomes of robotic-assisted (da Vinci®) inguinal hernia repair and compare perioperative outcomes with those associated with open hernia repair by the same participating surgeon.
Detailed description
This study is a retrospective data collection from existing medical records, is observational in nature and is designed to evaluate feasibility, safety and performance of the da Vinci® surgical system for patients who have undergone inguinal hernia repair surgery during the time period from initiation of robotic-assisted surgery to 30 days prior to study initiation (IRB approval and fully executed data collection agreement) for approximately 500 subjects. Any inguinal hernia repair procedure that uses the da Vinci® surgical system at any point will be collected.
This data will be compared with data associated with open inguinal hernia repairs performed by the same surgeons from a period of 5 years prior to the initiation of robotic surgery at each participating institution until 30 days prior to study initiation. Sites will collect data from consecutive open inguinal hernia repair cases starting with the day prior to the 1st robotic-assisted inguinal hernia repair, and continue collecting data until the number of open inguinal hernia repair cases is equivalent to the number of robotic-assisted inguinal hernia repair cases, or until the open repair procedure date reaches 5 years prior to the 1st robotic-assisted inguinal hernia repair case.
Data collected will include, but is not limited to, the following:
- Demographics and baseline/pre-operative clinical parameters: Gender, age, BMI, comorbidities, smoking history, prior hernia history, prior abdominal surgery history, hernia description
- Intraoperative parameters: procedure details related to repair, operative time, conversions to open, blood loss, intraoperative complications
- Post-operative through discharge : length of hospital stay, post-operative complications
- Post-operative information regarding complications, readmissions and reoperations through 30 days post-discharge.
- Hernia Recurrence, if available
The total duration for this study will be approximately 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-Assisted Inguinal Hernia Repair | – | Procedure: Inguinal Hernia RepairSubjects who have undergone robotic-assisted (da Vinci) inguinal hernia repair from the initiation of robotic-assisted hernia repair at site through December 2015. |
| Open Inguinal Hernia Repair | – | Procedure: Inguinal Hernia RepairSubjects who have undergone open inguinal hernia repair from the day prior to initiation of robotic-assisted hernia repair through 5 years prior to initiation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All subjects who have undergone robotic-assisted inguinal hernia repair or open hernia repair per specified time frame described in inclusion/exclusion criteria
Key inclusion criteria (4 listed)
- all patients who have undergone inguinal hernia repair using either an open technique or a robotic-assisted (da Vinci®) approach
- Eligible subjects must have had their inguinal hernia repair completed according to the following timeframes for inclusion:
- Robotic-assisted (da Vinci®) hernia repair - all consecutive robotic cases from the initiation of robotic -assisted inguinal hernia repair at each institution until 30 days prior to the date of study initiation (IRB approval and fully executed contract).
- Open hernia repair - all consecutive open hernia repair cases from the day prior to the 1st da Vinci® inguinal hernia repair until the number of open repair cases collected is equivalent to the number of da Vinci® cases entered, or the date 5 years pre-robotic initiation is reached.
Key exclusion criteria (1 listed)
- Subjects who have undergone robotic-assisted or open inguinal hernia repair outside of required timeframe
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 |
|---|---|---|
| Inguinal Hernia RepairAlso: HerniorrhaphyInguinal (unilateral or bilateral) hernia repair | Procedure or surgery | Open Inguinal Hernia Repair, Robotic-Assisted Inguinal Hernia Repair |
Primary outcome
Number of complications observed intraoperatively through 30-days
Time frame: Intraoperative through 30-days follow-up
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 28 Mar 2017.
- Derived from this study: PubMed 29713930Dickens EO, Kolachalam R, Gonzalez A, Richardson C, D'Amico L, Rabaza J, Gamagami R. Does robotic-assisted transabdominal preperitoneal (R-TAPP) hernia repair facilitate contralateral investigation and repair without compromising patient morbidity? J Robot Surg. 2018 Dec;12(4):713-718. doi: 10.1007/s11701-018-0815-4. Epub 2018 Apr 30.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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.
2 sites 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 and Hernia, Inguinal, Direct, run by Intuitive Surgical at 2 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 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: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Number of complications observed intraoperatively through 30-days (time frame: Intraoperative through 30-days follow-up). 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 NCT02684448, 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 28 Mar 2017.