HerniaNCT02715622
A Prospective Study to Compare the Clinical Outcomes, Pain and Patient Quality of Life for Hernia Patients
An observational study of Hernia and Incisional Hernia, run by Intuitive Surgical at 17 sites in United States.
Trial summary
The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Incisional Hernia, Hernia, Inguinal, Indirect
- What is being tested?
- Hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 944 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2016to Oct 2022
- How long will I take part?
- 3 Years
- 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: At least 900 patients will be enrolled in this post-market study that is planned to be conducted for mainly 2 types of hernia repairs, Incisional hernia repair and inguinal hernia repair ( robotic-assisted, lap and open). Up to 2000 patients may be enrolled. Approximately 450 patients who will undergo inguinal hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) and approximately 450 patients who will undergo incisional hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) will be enrolled in this study at up to thirty (30) study centers
Who may be able to join
- Age 18 years and older
- All patients undergoing either an open, laparoscopic or robotic-assisted
- Incisional or Inguinal Hernia repair procedure
- Non-Emergent Incisional or Inguinal Hernia Repair cases
Who cannot join
- Emergent Cases for both Incisional and Inguinal Hernia
- Incisional Hernia related to ostomy formation
- Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Mercy Medical Center
Baltimore, Maryland, 21202
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Beverly Hills Hernia Center
Beverly Hills, California, 90210
Southern Illinois Healthcare
Carbondale, Illinois, 62901
Florida Hospital - Celebration Health
Celebration, Florida, 34747
Rush University Medical Center
Chicago, Illinois, 60612
The Dallas VA Research Corporation
Dallas, Texas, 75216
Spectrum Health System
Grand Rapids, Michigan, 49503
Louisville Surgical Associates
Louisville, Kentucky, 40215
University of Tennessee
Memphis, Tennessee, 38120
Vanderbilt University Medical Center
Nashville, California, 37232
Progressive Surgical Associates
New Lenox, Illinois, 60451
The Mount Sinai Medical Center
New York, New York, 10029
Kaiser Foundation Research Institute
Oakland, California, 94612
Baptist Health South Florida
South Miami, Florida, 33143
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
New Hanover Regional Medical Center
Wilmington, North Carolina, 28403
About this study
Official title: A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair
The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.
The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.
- Conditions
- Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct, Inguinal Hernia
- Being tested
- Hernia repair
- Medical subject headings
- Hernia, Incisional Hernia, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hernia repairProcedure or surgery
Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
| Study group | Role | What they receive |
|---|---|---|
| Open Hernia Repair | A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure Receives: Procedure: Hernia repair | |
| Laparoscopic Hernia Repair | A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure Receives: Procedure: Hernia repair | |
| Robotic Hernia Repair | A minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure Receives: Procedure: 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
Number of intraoperative and short-term complications related to hernia repair.
Measured: 30 days
Number of patient reported complications post 30-days through 3 years post procedure
Number of long-term complications related to hernia repair directly reported by patients
Measured: 30 days post-procedure to 3 years post-procedure
Secondary outcomes (3)
Patient reported outcomes on Quality of Life through 1 year
Use of quality of life questionnaires (Carolinas Comfort Scale or HerQles Abdominal Questionnaire) will be used to assess patient qualify of life pre-procedure and post-procedure through 1 year.
Measured: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life
Incisional or Inguinal Hernia Recurrence through 3 years
Number of hernia recurrences for each patient will be patient reported through 3 years post-procedure.
Measured: 30 days post-procedure through 3 years
Patient reported outcomes on post-procedure pain through 3 years
Pain medication taken by patient (type, dosage and quantity of pills) will also be captured through patient reported methods. Unit of measure will be numerical count of pills take
Measured: 2-4 weeks post-procedure through 3 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies 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
- 944 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Responsible party
- Sponsor
- Investigators
- Karl LeBlanc, MD, Study chair, Surgeon Group of Baton Rouge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715622
- Sponsor's protocol ID
- ISI-PHS-2016
- Status last verified
- Feb 2023
- First submitted
- 19 Feb 2016
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
LeBlanc KA, Gonzalez A, Dickens E, Olsofka J, Ortiz-Ortiz C, Verdeja JC, Pierce R; Prospective Hernia Study Group. Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study. Hernia. 2021 Aug;25(4):1071-1082. doi: 10.1007/s10029-021-02381-0. Epub 2021 May 24.
PubMed 34031762LeBlanc KA. Design of a comparative outcome analysis of open, laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model. Contemp Clin Trials. 2019 Nov;86:105853. doi: 10.1016/j.cct.2019.105853. Epub 2019 Oct 25.
PubMed 31669560
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Post-Market Study to Evaluate and Compare the Clinical Outcomes, Pain and Patient Quality of Life After Open, Laparoscopic or Robotic Assisted Hernia (Incisional and Inguinal) Repair
- ClinicalTrials.gov ID
- NCT02715622
- Acronym / sponsor ID
- ISI-PHS-2016
- Conditions
- Hernia, Incisional Hernia, Hernia, Inguinal, Indirect, Hernia, Inguinal, Direct, Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 944 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Collaborators
- Accelovance
- Study start
- Apr 2016
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 22 Mar 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.
The objective of this prospective, multi-center post-market study is to prospectively collect uniform, evidence based outcomes for patients undergoing open, laparoscopic or robotic assisted hernia repair.
The outcomes that will be collected include various routine clinical parameters, short term patient reported outcomes (quality of life, pain scores) and long term hernia recurrence information. Patients will be treated according to standard of care at the surgeon's institution and patients will be followed up to collect information related to complications information and patient satisfaction associated with the hernia repair procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Hernia Repair | – | Procedure: Hernia repairA minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia open repair surgical procedure |
| Laparoscopic Hernia Repair | – | Procedure: Hernia repairA minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia laparoscopic repair surgical procedure |
| Robotic Hernia Repair | – | Procedure: Hernia repairA minimum of 300 patients will be enrolled in the Incisional and Inguinal Hernia robotic-assisted laparoscopic repair surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 900 patients will be enrolled in this post-market study that is planned to be conducted for mainly 2 types of hernia repairs, Incisional hernia repair and inguinal hernia repair ( robotic-assisted, lap and open). Up to 2000 patients may be enrolled. Approximately 450 patients who will undergo inguinal hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) and approximately 450 patients who will undergo incisional hernia repair across open, laparoscopic or robotic-assisted procedures (~ 150 patients in each surgical modality) will be enrolled in this study at up to thirty (30) study centers
Key inclusion criteria (4 listed)
- Age 18 years and older
- All patients undergoing either an open, laparoscopic or robotic-assisted
- Incisional or Inguinal Hernia repair procedure
- Non-Emergent Incisional or Inguinal Hernia Repair cases
Key exclusion criteria (3 listed)
- Emergent Cases for both Incisional and Inguinal Hernia
- Incisional Hernia related to ostomy formation
- Incisional Hernia requiring component separation (determined pre-operatively or intraoperatively)
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 |
|---|---|---|
| Hernia repairPatient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice | Procedure or surgery | Laparoscopic Hernia Repair, Open Hernia Repair, Robotic Hernia Repair |
Primary outcome
Number of complications observed intraoperatively through 30 days
Time frame: 30 days
Number of intraoperative and short-term complications related to hernia repair.
Number of patient reported complications post 30-days through 3 years post procedure
Time frame: 30 days post-procedure to 3 years post-procedure
Number of long-term complications related to hernia repair directly reported by patients
3 secondary outcomes
Patient reported outcomes on Quality of Life through 1 year
Time frame: Pre-procedure (baseline) and 30 days through 1 year for Qualify of Life
Incisional or Inguinal Hernia Recurrence through 3 years
Time frame: 30 days post-procedure through 3 years
Patient reported outcomes on post-procedure pain through 3 years
Time frame: 2-4 weeks post-procedure through 3 years post-procedure
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 Mar 2023.
- Derived from this study: PubMed 34031762LeBlanc KA, Gonzalez A, Dickens E, Olsofka J, Ortiz-Ortiz C, Verdeja JC, Pierce R; Prospective Hernia Study Group. Robotic-assisted, laparoscopic, and open incisional hernia repair: early outcomes from the Prospective Hernia Study. Hernia. 2021 Aug;25(4):1071-1082. doi: 10.1007/s10029-021-02381-0. Epub 2021 May 24.
- Derived from this study: PubMed 31669560LeBlanc KA. Design of a comparative outcome analysis of open, laparoscopic, or robotic-assisted incisional or inguinal hernia repair utilizing surgeon experience and a novel follow-up model. Contemp Clin Trials. 2019 Nov;86:105853. doi: 10.1016/j.cct.2019.105853. Epub 2019 Oct 25.
- Individual participant dataSharing planned: Undecided
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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.
Karl LeBlanc, MD study chair
Surgeon Group of Baton Rouge
17 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 and Incisional Hernia, run by Intuitive Surgical at 17 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 3 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 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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: 30 days). 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?
On the ClinicalTrials.gov record for NCT02715622, which also lists 2 linked publications.
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 Mar 2023.