Trial Outcomes & Findings for Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM (NCT NCT03283982)
NCT ID: NCT03283982
Last Updated: 2022-07-25
Results Overview
Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"); This will be reported using median and interquartile ranges
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
Pain scores will be assessed on postoperative day 1, day 7 and day 30
Results posted on
2022-07-25
Participant Flow
Participant milestones
| Measure |
Robotic IPOM
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
36
|
|
Overall Study
COMPLETED
|
39
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laparoscopic vs. Robotic Ventral Hernia Repair With IPOM
Baseline characteristics by cohort
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 Years
n=99 Participants
|
55.5 Years
n=107 Participants
|
56 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black/ African American
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pain scores will be assessed on postoperative day 1, day 7 and day 30Pain scores will be assessed using the Numeric Pain Rating Scale (NRS-11); The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"); This will be reported using median and interquartile ranges
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Postoperative Pain Scores
Post Surgery Day 1
|
5 score on a scale
Interval 3.0 to 6.0
|
5 score on a scale
Interval 3.0 to 7.0
|
|
Postoperative Pain Scores
Post Surgery Day 7
|
4 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 2.0 to 5.0
|
|
Postoperative Pain Scores
Post Surgery Day 30
|
1 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 0.0 to 3.5
|
PRIMARY outcome
Timeframe: 30 days(+-15days) postoperativelyPain scores will be assessed using the PROMIS (Patient-Reported Outcomes Measurement Information System) 3a Pain Intensity Survey. Measured on a scale of 30.7- 71.8 with the higher numbers indicating higher pain
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Postoperative Pain Scores
|
44.9 score on a scale
Interval 40.2 to 50.1
|
46.3 score on a scale
Interval 40.2 to 49.4
|
SECONDARY outcome
Timeframe: 12 months +- 3 monthsVentral Hernia recurrence will be assessed at 1 year postoperatively, either by physical examination, imaging studies or using the validated Ventral Hernia Recurrence Inventory Survey. Rates of ventral hernia recurrence will be reported as percent
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Number of Participants With Central Hernia Recurrence
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Start of procedure to end of procedure which is an average of 2 hoursOutcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Cost of Robotic IPOM Versus Laparoscopic IPOM
|
2438 American Dollars
Interval 1942.0 to 3245.0
|
2102 American Dollars
Interval 1826.0 to 2530.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-days(+-15days) postoperativelyAbdominal Wall Specific Quality of Life will be assessed using the validated HerQLes (Hernia Related Quality of Life) survey. Scores will be reported as mean and standard deviations as appropriate on a scale from 0-100 with the larger numbers representing higher quality of life.
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Abdominal Wall Specific Quality of Life
|
67 score on a scale
Interval 46.0 to 80.8
|
72 score on a scale
Interval 35.0 to 80.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days +- 15 daysSurgical site infection rates will be assessed and reported as percent
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Number of Participants With Surgical Site Infection
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days +- 15 daysSurgical Site Occurrences requiring Procedural Intervention will be assessed and reported as percent
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Number of Participants With Surgical Site Occurrences Requiring Procedural Intervention
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30-days +- 15 daysSurgical site occurrences ( defined as wound cellulitis, non-healing wound, fascial disruption, skin or soft tissue ischemia or necrosis, wound drainage, stitch abscess, seroma, hematoma, exposed, contaminated or infected mesh and enterocutaneous fistula) will be assessed and reported as percent
Outcome measures
| Measure |
Robotic IPOM
n=39 Participants
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 Participants
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Number of Participants With Surgical Site Occurrences
None
|
38 Participants
|
36 Participants
|
|
Number of Participants With Surgical Site Occurrences
Yes
|
1 Participants
|
0 Participants
|
Adverse Events
Robotic IPOM
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Laparoscopic IPOM
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Robotic IPOM
n=39 participants at risk
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 participants at risk
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
Vascular disorders
Pulmonary Embolism
|
2.6%
1/39 • Number of events 1 • 1 year post surgery
|
0.00%
0/36 • 1 year post surgery
|
Other adverse events
| Measure |
Robotic IPOM
n=39 participants at risk
Robotic Ventral Hernia Repair with IPOM: The da Vinci® Surgical System robotic platform (Intuitive Surgical, Inc.) will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Robotic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
|
Laparoscopic IPOM
n=36 participants at risk
Laparoscopic Ventral Hernia Repair with IPOM: The standard laparoscopic platform will be used to perform a minimally invasive ventral hernia repair with intraperitoneal mesh placement.
Laparoscopic Ventral Hernia Repair with IPOM: Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
|
|---|---|---|
|
General disorders
Pain
|
2.6%
1/39 • Number of events 1 • 1 year post surgery
|
5.6%
2/36 • Number of events 2 • 1 year post surgery
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/39 • 1 year post surgery
|
8.3%
3/36 • Number of events 3 • 1 year post surgery
|
|
Gastrointestinal disorders
Bowel Obstruction
|
0.00%
0/39 • 1 year post surgery
|
2.8%
1/36 • Number of events 1 • 1 year post surgery
|
|
Gastrointestinal disorders
Constipation
|
2.6%
1/39 • Number of events 1 • 1 year post surgery
|
0.00%
0/36 • 1 year post surgery
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/39 • Number of events 1 • 1 year post surgery
|
0.00%
0/36 • 1 year post surgery
|
|
Surgical and medical procedures
Scar Revision
|
2.6%
1/39 • Number of events 1 • 1 year post surgery
|
0.00%
0/36 • 1 year post surgery
|
|
Surgical and medical procedures
Access-Related Injury
|
2.6%
1/39 • Number of events 1 • 1 year post surgery
|
0.00%
0/36 • 1 year post surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place