Ventral HerniaNCT03133715
Laparoscopic Versus Robot-assisted Ventral Hernia Repair: a Single Institution Randomized Controlled Trial
A study testing laparoscopic repair and robot-assisted repair in people with Ventral Hernia, run by University of Florida at 1 site in United States.
Trial summary
Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- laparoscopic repair and robot-assisted repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to Jun 2023
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- surgeon determined need for ventral hernia repair
Who cannot join
- <18 \& >99 years of age
- Pregnant
- Medical indication for open repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial
Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.
Read the detailed description
Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.
- Conditions
- Ventral Hernia
- Being tested
- laparoscopic repair, robot-assisted repair
- Keywords
- robot-assisted
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic repairProcedure or surgery
surgical repair of ventral hernia using laparoscopic repair
robot-assisted repairProcedure or surgery
surgical repair of ventral hernia using robot-assisted repair
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic ventral hernia | Active comparator | laparoscopic ventral hernia repair Receives: Procedure: laparoscopic repair |
| robot-assisted ventral hernia | Active comparator | robot-assisted ventral hernia repair Receives: Procedure: robot-assisted repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
time from start to finish of procedure, procedure start and stop times as recorded by anesthesia
Measured: perioperative time
Secondary outcomes (1)
Post operative pain score
Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, and one year postoperatively
Measured: until year five post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 May 2019 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Study not IRB approved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Model description
- Participants will be randomized to receive either laparoscopic or robot-assisted repair of ventral hernia.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Latzko, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133715
- Sponsor's protocol ID
- IRB201601533
- Status last verified
- Jun 2018
- First submitted
- 25 Apr 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03133715
- Acronym / sponsor ID
- IRB201601533
- Conditions
- Ventral Hernia
- Keywords
- robot-assisted
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not IRB approved.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Apr 2017 (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.
Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.
Detailed description
Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive either laparoscopic or robot-assisted repair of ventral hernia.
| Arm | Type | Receives |
|---|---|---|
| laparoscopic ventral hernia | Active comparator | Procedure: laparoscopic repairlaparoscopic ventral hernia repair |
| robot-assisted ventral hernia | Active comparator | Procedure: robot-assisted repairrobot-assisted ventral hernia repair |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- surgeon determined need for ventral hernia repair
Key exclusion criteria (3 listed)
- <18 \& >99 years of age
- Pregnant
- Medical indication for open repair
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 repairsurgical repair of ventral hernia using laparoscopic repair | Procedure or surgery | laparoscopic ventral hernia |
| robot-assisted repairsurgical repair of ventral hernia using robot-assisted repair | Procedure or surgery | robot-assisted ventral hernia |
Primary outcome
Operative time
Time frame: perioperative time
time from start to finish of procedure, procedure start and stop times as recorded by anesthesia
1 secondary outcome
Post operative pain score
Time frame: until year five post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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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 Latzko, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic repair and robot-assisted repair in people with Ventral Hernia, run by University of Florida 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 1 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: withdrawn, as of the sponsor's last update on 24 Jan 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Operative time (time frame: perioperative time). 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 24 Jan 2019.