Trial Outcomes & Findings for Open Versus Robotic Retromuscular Ventral Hernia Repair (NCT NCT03007758)
NCT ID: NCT03007758
Last Updated: 2025-08-07
Results Overview
A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.
COMPLETED
NA
101 participants
Through study completion, an average of 2 years
2025-08-07
Participant Flow
After screening, 101 patients were consented.
One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair).
Participant milestones
| Measure |
Robotic Ventral Hernia Repair (VHR)
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
Open VHR
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
51
|
|
Overall Study
Randomization
|
50
|
50
|
|
Overall Study
Surgery
|
48
|
45
|
|
Overall Study
Completed 30-Day Follow-up
|
45
|
44
|
|
Overall Study
Analysis of 30-day Outcomes
|
46
|
44
|
|
Overall Study
Analysis of 2-year Outcomes
|
32
|
30
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
18
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Open Versus Robotic Retromuscular Ventral Hernia Repair
Baseline characteristics by cohort
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Comorbidities
HTN
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Comorbidities
DM
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Comorbidities
COPD
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Active Smoker
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
ASA
2
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
ASA
3
|
32 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
ASA
4
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Hernia Type
Incisional
|
44 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Hernia Type
Primary Ventral
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Hernia Type
Parastomal
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Hernia Type
Recurrent Hernia
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Number of Prior Repairs
None
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Number of Prior Repairs
1
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Number of Prior Repairs
2
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Number of Prior Repairs
3 or more
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Prior Mesh Present
|
7 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Myofascial release
Posterior rectus sheath only
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Myofascial release
Transversus Abdominis Release
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Intraoperative Complications
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Bowel Injury (serosa)
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Bowel Injury (full-thickness)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 2 yearsPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 robotic RMVHR and 44 open RMVHR patients for analysis of the primary outcome.
A composite outcome of events which are clinically significant including but not limited to seroma requiring procedural intervention, skin dehiscence, cellulitis, hematoma, skin necrosis, and surgical site infections which may require interventions such as wound care or antibiotic therapy.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 yearsPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
All Surgical Site Occurrences
|
8 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 yearsPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Surgical Site Occurrences Requiring Procedural Intervention
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 yearsPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
All Surgical Site Infections
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 yearsPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Surgical Site Infections Requiring Procedural Intervention
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Time from procedure until discharge, an expected range of 2 to10 daysPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Length of Stay at Hospital Measured in Days
|
1 days
Interval 0.0 to 5.0
|
2 days
Interval 0.0 to 5.0
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Operative Time (Procedure Start to Procedure Finish Measured in Minutes)
|
206 minutes
Interval 184.0 to 237.0
|
156 minutes
Interval 130.0 to 205.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 2 yearsPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Cost for Hospital Charges From Billing Office
|
11747 U.S. Dollars
Interval 9717.0 to 13530.0
|
9267 U.S. Dollars
Interval 8873.0 to 11641.0
|
SECONDARY outcome
Timeframe: Measured at study enrollmentPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Body Mass Index
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
BMI
|
36.7 kg/m^2
Interval 30.6 to 41.9
|
36.7 kg/m^2
Interval 31.6 to 40.2
|
SECONDARY outcome
Timeframe: measured at surgeryPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Width of Hernia
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Hernia Width
|
8 cm
Interval 6.0 to 10.0
|
10 cm
Interval 8.0 to 12.0
|
SECONDARY outcome
Timeframe: measured at surgeryPopulation: After screening, 101 patients were consented. One patient withdrew from the study prior to surgery, leaving 100 patients randomized for inclusion. A total of 7 patients were randomized but never went through with surgery (5 randomized to open, 2 randomized to robotic repair). Two patients in the robotic arm and one in the open arm did not complete 30-day follow-up and were excluded, leaving 46 rRMVHR and 44 RMVHR patients for analysis of the primary outcome.
Length of Hernia
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=44 Participants
Open VHR
|
|---|---|---|
|
Hernia Length
|
15 cm
Interval 12.0 to 20.0
|
15 cm
Interval 10.0 to 19.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 30 daysPopulation: 41 patients in the robotic arm completed the 30 day PROs and 41 patients in the open arm completed the 30 day PROs.
Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6. The score is calculated with the following formula: (120-\[(20/12)\*(sum of response on all 12 questions)\]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=41 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=41 Participants
Open VHR
|
|---|---|---|
|
Quality of Life Via Questionnaire - 30 Days
Baseline Patient Reported Outcomes
|
34 units on a scale
Interval 16.0 to 52.0
|
28 units on a scale
Interval 16.0 to 64.0
|
|
Quality of Life Via Questionnaire - 30 Days
30 Day Patient Reported Outcomes
|
38 units on a scale
Interval 18.0 to 68.0
|
50 units on a scale
Interval 34.0 to 58.0
|
|
Quality of Life Via Questionnaire - 30 Days
Difference
|
0 units on a scale
Interval -22.0 to 32.0
|
16 units on a scale
Interval -20.0 to 30.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 6 through 12 months. Data for the 6 and 12-month patient reported outcomes were combined for analysis.Population: 39 patients in the robotic arm completed the 6 or 12 month PROs and 33 patients in the open arm completed the 6 or 12 month PROs. Data collected at both 6 month and 12 month time points but they were combined for analysis.
Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6.The score is calculated with the following formula: (120-\[(20/12)\*(sum of response on all 12 questions)\]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=39 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=33 Participants
Open VHR
|
|---|---|---|
|
Quality of Life Via Questionnaire - 6 Through 12 Months
Baseline Patient Reported Outcomes
|
26 units on a scale
Interval 12.0 to 40.0
|
46 units on a scale
Interval 34.0 to 80.0
|
|
Quality of Life Via Questionnaire - 6 Through 12 Months
6-12 month Patient Reported Outcomes
|
86 units on a scale
Interval 64.0 to 94.0
|
90 units on a scale
Interval 72.0 to 96.0
|
|
Quality of Life Via Questionnaire - 6 Through 12 Months
Difference
|
60 units on a scale
Interval 22.0 to 78.0
|
20 units on a scale
Interval 10.0 to 54.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 24 monthsPopulation: 32 patients in the robotic arm completed the 24 month patient reported outcomes and 30 patients in the open arm completed the 24 month patient reported outcomes.
Patient reported outcomes via the Hernia related quality of life score. The survey contains 12 statements about the patients abdominal wall and asks the patient to rate how strongly the disagree (1) or agree (6) with the statements on a scale 1-6. The score is calculated with the following formula: (120-\[(20/12)\*(sum of responses on all 12 questions)\]).The highest possible number, meaning the abdominal wall does not affect the patient, is 100, and the lowest, meaning the abdominal wall greatly affects the patient's quality of life, is a 0.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=32 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=30 Participants
Open VHR
|
|---|---|---|
|
Quality of Life Via Questionnaire - 24 Months
Baseline Patient Reported Outcomes
|
36 units on a scale
Interval 21.0 to 69.0
|
32 units on a scale
Interval 16.0 to 50.0
|
|
Quality of Life Via Questionnaire - 24 Months
24 month Patient Reported Outcomes
|
80 units on a scale
Interval 42.0 to 92.0
|
91 units on a scale
Interval 76.0 to 94.0
|
|
Quality of Life Via Questionnaire - 24 Months
Difference
|
28 units on a scale
Interval -5.0 to 56.0
|
59 units on a scale
Interval 14.0 to 64.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 30 days.Population: 41 patients in the robotic arm completed the 24 month patient reported outcomes and 41 patients in the open arm completed the 24 month patient reported outcomes.
Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=41 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=41 Participants
Open VHR
|
|---|---|---|
|
Pain Score - 30 Day Patient Reported Outcomes
Baseline Patient Reported outcomes
|
2 units on a scale
Interval 1.0 to 2.0
|
3 units on a scale
Interval 2.0 to 3.0
|
|
Pain Score - 30 Day Patient Reported Outcomes
30 Day Patient reported outcomes
|
3 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 2.0 to 3.0
|
|
Pain Score - 30 Day Patient Reported Outcomes
Difference
|
1 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval -1.0 to 1.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis.Population: 39 patients in the robotic arm completed the 6 or 12 month patient reported outcomes and 33 patients in the open arm completed the 6 or 12 month patient reported outcomes. Data collected at both 6 month and 12 month time points but they were combined for analysis.
Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=39 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=33 Participants
Open VHR
|
|---|---|---|
|
Pain Score - 6 or 12 Month Patient Reported Outcomes
Baseline Patient Reported outcomes
|
2 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
|
Pain Score - 6 or 12 Month Patient Reported Outcomes
6 or 12 month Patient reported outcomes
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 2.0
|
|
Pain Score - 6 or 12 Month Patient Reported Outcomes
Difference
|
-1 units on a scale
Interval -2.0 to 0.0
|
-1 units on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 24 monthsPopulation: 32 patients in the robotic arm completed the 24 month patient reported outcomes and 30 patients in the open arm completed the 24 month patient reported outcomes.
Patient is asked 3 different questions all in relation to their pain in the past 7 days: how intense was it as its worst, on average, and right now. They then rank their pain for each question on a scale of 1 - 5. 1 meaning no pain and 5 very severe pain. The pain scores were then averaged and used for this analysis.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=32 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=30 Participants
Open VHR
|
|---|---|---|
|
Pain Score - 24 Month Patient Reported Outcomes
Baseline Patient Reported outcomes
|
2 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 2.0 to 3.0
|
|
Pain Score - 24 Month Patient Reported Outcomes
24 month Patient reported outcomes
|
1 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 1.0 to 1.0
|
|
Pain Score - 24 Month Patient Reported Outcomes
Difference
|
-1 units on a scale
Interval -1.5 to 0.0
|
-1 units on a scale
Interval -2.0 to 0.0
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 12 months.Population: 39 patients in the robotic arm completed the 12 month patient reported outcomes and 33 patients in the open arm completed the 12 month patient reported outcomes.
Patients are asked 3 yes or no questions about their hernia operation: do you feel your hernia has come back, do you feel or see a bulge, and do you have physical pain or symptoms at the site.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=39 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=33 Participants
Open VHR
|
|---|---|---|
|
Ventral Hernia Recurrence Inventory 1 Year
Bulging at hernia site
|
16 count of "yes" answers
|
7 count of "yes" answers
|
|
Ventral Hernia Recurrence Inventory 1 Year
Pain at hernia site
|
9 count of "yes" answers
|
5 count of "yes" answers
|
|
Ventral Hernia Recurrence Inventory 1 Year
Do you feel your hernia has come back?
|
2 count of "yes" answers
|
2 count of "yes" answers
|
SECONDARY outcome
Timeframe: assessed at Baseline and Post-operatively at 24 monthsPopulation: 32 patients in the robotic arm completed the 24 month patient reported outcomes and 30 patients in the open arm completed the 24 month patient reported outcomes.
Patients are asked 3 yes or no questions about their hernia operation: do you feel your hernia has come back, do you feel or see a bulge, and do you have physical pain or symptoms at the site.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=32 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=30 Participants
Open VHR
|
|---|---|---|
|
Ventral Hernia Recurrence Inventory 2 Years
Pain at hernia site
|
8 count of "yes" answers
|
4 count of "yes" answers
|
|
Ventral Hernia Recurrence Inventory 2 Years
Bulging at hernia site
|
11 count of "yes" answers
|
3 count of "yes" answers
|
|
Ventral Hernia Recurrence Inventory 2 Years
Do you feel your hernia has come back?
|
7 count of "yes" answers
|
1 count of "yes" answers
|
SECONDARY outcome
Timeframe: assessed Post-operatively as 24 monthsPopulation: 32 patients in the robotic arm completed the 24 month patient reported outcomes and 30 patients in the open arm completed the 24 month patient reported outcomes.
The ventral hernia recurrence inventory asked patients if they have had any additional surgery since the hernia operation. If they answer yes, they choose if the surgery was for a hernia or another reason. The answers from 1 year follow up and 2 year follow up to the last question were combined for this analysis. Composite recurrence was then determined by excluding patients with negative CT scan or physical exam but had answered the ventral hernia recurrence inventory indication the hernia recurrence.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=32 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=30 Participants
Open VHR
|
|---|---|---|
|
Hernia Recurrence
Ventral Hernia Recurrence Inventory - Recurrence at 2 years
|
11 Participants
|
4 Participants
|
|
Hernia Recurrence
Composite Recurrence
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed at index surgery.Population: Patient who are randomized to receive an open ventral hernia repair were not assessed for Conversion to Open
Robotic surgeries converted to open surgeries.
Outcome measures
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=46 Participants
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
Open VHR
|
|---|---|---|
|
Conversion to Open
|
5 Participants
|
0 Participants
|
Adverse Events
Robotic Ventral Hernia Repair (VHR)
Open Ventral Hernia Repair (VHR)
Serious adverse events
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=50 participants at risk
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=51 participants at risk
Open VHR
|
|---|---|---|
|
Surgical and medical procedures
Hematoma
|
6.0%
3/50 • Number of events 3 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
|
Gastrointestinal disorders
small bowel obstruction
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
Wound infection
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
5.9%
3/51 • Number of events 3 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
Intraperietal hernia
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
Post surgical spine infection
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Musculoskeletal and connective tissue disorders
Motor vehicle accident
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Musculoskeletal and connective tissue disorders
Total left hip anthroplast
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
Other adverse events
| Measure |
Robotic Ventral Hernia Repair (VHR)
n=50 participants at risk
Robotic VHR
|
Open Ventral Hernia Repair (VHR)
n=51 participants at risk
Open VHR
|
|---|---|---|
|
Surgical and medical procedures
Seroma
|
12.0%
6/50 • Number of events 6 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Endocrine disorders
progressive renal insufficiency
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
Enterotomies
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
Hematoma
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Skin and subcutaneous tissue disorders
inguinal hernia repair
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Skin and subcutaneous tissue disorders
Superficial skin infection
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Nervous system disorders
Whiplash
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
Abdominal pain
|
4.0%
2/50 • Number of events 2 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Renal and urinary disorders
Ureteral stone
|
0.00%
0/50 • From enrollment until end of follow up (2 years after surgery)
|
2.0%
1/51 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
|
Surgical and medical procedures
abdominal wall bulge
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Renal and urinary disorders
rectal bleeding
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
|
Gastrointestinal disorders
Constipation
|
2.0%
1/50 • Number of events 1 • From enrollment until end of follow up (2 years after surgery)
|
0.00%
0/51 • From enrollment until end of follow up (2 years after surgery)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place