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The purpose of this study is to determine how the robotic retromuscular hernia repair compares to the open retromuscular hernia repair for large hernia defects in patients at higher risk of wound complications.
All patients presenting to the Greenville Health System Hernia Center who meet the inclusion criteria will be considered for enrollment. Patients who qualify and agree to participate will be randomized 1:1 to robotic retromuscular ventral hernia repair or open retromuscular ventral hernia repair. Data to be collected includes the following: demographic information, medical characteristics, medications, medical and surgical history, operative details, hospital stay data, and patient-reported outcomes via a quality of life questionnaire. Post-operative follow-up will occur at 2 weeks, 6 weeks, 6 months, 1 year and 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| robotic ventral hernia repair (VHR) | Active Comparator | Robotic VHR |
|
| open ventral hernia repair (VHR) | Active Comparator | Open VHR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open ventral hernia repair | Procedure | An open retromuscular ventral hernia repair involves an incision through your abdominal wall, most often through a prior surgery scar. The contents of the hernia, which may include intestine or fatty tissue, are returned into the abdominal cavity. The posterior (inner-most) layer of the abdominal wall is separated from the muscle and closed, which closes the abdominal cavity. Mesh is then placed over that closed layer, which is outside of the abdominal cavity, but below the abdominal muscles. The anterior (outer-most) layer of the abdominal wall is then closed over the mesh, which closes the hernia. |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence | 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. | Through study completion, an average of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| All Surgical Site Occurrences | Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections. | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
| Surgical Site Occurrences Requiring Procedural Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy A Warren, MD | Prisma Health-Upstate | Principal Investigator |
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All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.
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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).
After screening, 101 patients were consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Ventral Hernia Repair (VHR) | Robotic VHR |
| FG001 | Open Ventral Hernia Repair (VHR) | Open VHR |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Ventral Hernia Repair (VHR) | Robotic VHR |
| BG001 | Open Ventral Hernia Repair (VHR) | Open VHR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence | 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. | 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. | Posted | Count of Participants | Participants | Through study completion, an average of 2 years |
|
From enrollment until end of follow up (2 years after surgery)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robotic Ventral Hernia Repair (VHR) | Robotic VHR | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Surgical and medical procedures | Non-systematic Assessment | Pt was admitted to the hospital on 5/3/2018 for dizziness, blurred vision, and weakness. A CT scan was performed which showed a large hematoma at abdominal wall. Pt was put on anticoagulant Eliquis and discharged on 5/5/2018. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seroma | Surgical and medical procedures | Non-systematic Assessment | Patient developed a seroma. Patient came back into office and provider aspirated the seroma. Patient came back into office for their final study visit and provider again aspirated the seroma |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abby Birrell, Study Coordinator | Prisma Health | 8645222117 | abby.birrell@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2017 | May 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| robotic ventral hernia repair | Procedure | A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar mesh placement, and similar closure of the hernia defect. The surgical robot is a tool that allows your surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of your abdomen. Rather than one longer incision in the middle of your abdomen, four to six small incisions, about 1 inch, are made along the outer part of your abdomen between the rib cage and hip. |
|
Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections |
| Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
| All Surgical Site Infections | Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections. | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
| Surgical Site Infections Requiring Procedural Intervention | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
| Length of Stay at Hospital Measured in Days | Time from procedure until discharge, an expected range of 2 to10 days |
| Operative Time (Procedure Start to Procedure Finish Measured in Minutes) | Day of surgery |
| Cost for Hospital Charges From Billing Office | Through study completion, an average of 2 years |
| BMI | Body Mass Index | Measured at study enrollment |
| Hernia Width | Width of Hernia | measured at surgery |
| Hernia Length | Length of Hernia | measured at surgery |
| Quality of Life Via Questionnaire - 30 Days | 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. | assessed at Baseline and Post-operatively at 30 days |
| Quality of Life Via Questionnaire - 6 Through 12 Months | 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. | 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. |
| Quality of Life Via Questionnaire - 24 Months | 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. | assessed at Baseline and Post-operatively at 24 months |
| Pain Score - 30 Day 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. | assessed at Baseline and Post-operatively at 30 days. |
| Pain Score - 6 or 12 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. | assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis. |
| Pain Score - 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. | assessed at Baseline and Post-operatively at 24 months |
| Ventral Hernia Recurrence Inventory 1 Year | 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. | assessed at Baseline and Post-operatively at 12 months. |
| Ventral Hernia Recurrence Inventory 2 Years | 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. | assessed at Baseline and Post-operatively at 24 months |
| Hernia Recurrence | 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. | assessed Post-operatively as 24 months |
| Conversion to Open | Robotic surgeries converted to open surgeries. | Assessed at index surgery. |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants | No |
|
| Active Smoker | Count of Participants | Participants | No |
|
| ASA | ASA I: A person in good health. ASA II: A mild but well-managed or treated condition. ASA III: A serious condition that has an impact on a person's overall health. ASA IV: A severe condition that's life-threatening. ASA V: A life-threatening condition that needs immediate surgery to increase survival odds. ASA VI: A deceased person who is an organ donor. | Count of Participants | Participants | No |
|
| Hernia Type | Participants can be counted more than once in the incisional and recurrent hernia categories. | Count of Participants | Participants | No |
|
| Number of Prior Repairs | Count of Participants | Participants | No |
|
| Prior Mesh Present | Count of Participants | Participants | No |
|
| Myofascial release | 34 patients in the open arm received a posterior rectus sheath release only. 32 patients in the robotic arm received a posterior rectus sheath release only. 14 patients in the robotic arm and 10 patients in the open received a transversus abdominis release. | Count of Participants | Participants | No |
|
| Intraoperative Complications | Count of Participants | Participants | No |
|
| Bowel Injury (serosa) | Count of Participants | Participants | No |
|
| Bowel Injury (full-thickness) | Count of Participants | Participants | No |
|
Robotic VHR |
| OG001 | Open Ventral Hernia Repair (VHR) | Open VHR |
|
|
| Secondary | All Surgical Site Occurrences | Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections. | 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. | Posted | Count of Participants | Participants | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Surgical Site Occurrences Requiring Procedural Intervention | Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections | 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. | Posted | Count of Participants | Participants | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | All Surgical Site Infections | Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections. | 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. | Posted | Count of Participants | Participants | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Surgical Site Infections Requiring Procedural Intervention | 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. | Posted | Count of Participants | Participants | Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years |
|
|
|
| Secondary | Length of Stay at Hospital Measured in Days | 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. | Posted | Median | Inter-Quartile Range | days | Time from procedure until discharge, an expected range of 2 to10 days |
|
|
|
| Secondary | Operative Time (Procedure Start to Procedure Finish Measured in Minutes) | 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. | Posted | Median | Inter-Quartile Range | minutes | Day of surgery |
|
|
|
| Secondary | Cost for Hospital Charges From Billing Office | 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. | Posted | Median | Inter-Quartile Range | U.S. Dollars | Through study completion, an average of 2 years |
|
|
|
| Secondary | BMI | Body Mass Index | 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. | Posted | Median | Inter-Quartile Range | kg/m^2 | Measured at study enrollment |
|
|
|
| Secondary | Hernia Width | Width of Hernia | 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. | Posted | Median | Inter-Quartile Range | cm | measured at surgery |
|
|
|
| Secondary | Hernia Length | Length of Hernia | 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. | Posted | Median | Inter-Quartile Range | cm | measured at surgery |
|
|
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| Secondary | Quality of Life Via Questionnaire - 30 Days | 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. | 41 patients in the robotic arm completed the 30 day PROs and 41 patients in the open arm completed the 30 day PROs. | Posted | Median | Inter-Quartile Range | units on a scale | assessed at Baseline and Post-operatively at 30 days |
|
|
|
| Secondary | Quality of Life Via Questionnaire - 6 Through 12 Months | 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | 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. |
|
|
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| Secondary | Quality of Life Via Questionnaire - 24 Months | 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | assessed at Baseline and Post-operatively at 24 months |
|
|
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| Secondary | Pain Score - 30 Day 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | assessed at Baseline and Post-operatively at 30 days. |
|
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| Secondary | Pain Score - 6 or 12 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis. |
|
|
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| Secondary | Pain Score - 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | assessed at Baseline and Post-operatively at 24 months |
|
|
|
| Secondary | Ventral Hernia Recurrence Inventory 1 Year | 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. | 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. | Posted | Number | count of "yes" answers | assessed at Baseline and Post-operatively at 12 months. |
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| Secondary | Ventral Hernia Recurrence Inventory 2 Years | 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. | 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. | Posted | Number | count of "yes" answers | assessed at Baseline and Post-operatively at 24 months |
|
|
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| Secondary | Hernia Recurrence | 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. | 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. | Posted | Count of Participants | Participants | assessed Post-operatively as 24 months |
|
|
|
| Secondary | Conversion to Open | Robotic surgeries converted to open surgeries. | Patient who are randomized to receive an open ventral hernia repair were not assessed for Conversion to Open | Posted | Count of Participants | Participants | Assessed at index surgery. |
|
|
|
| 50 |
| 9 |
| 50 |
| 15 |
| 50 |
| EG001 | Open Ventral Hernia Repair (VHR) | Open VHR | 2 | 51 | 6 | 51 | 7 | 51 |
|
| small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment | bowel obstruction due to adhesions |
|
| Wound infection | Surgical and medical procedures | Non-systematic Assessment | wound infection that required inpatient care and drainage |
|
| Intraperietal hernia | Surgical and medical procedures | Non-systematic Assessment | Patient complained of a bursting, pulling sensation in her abdomen. CT scan showed an intraparietal hernia which was repaired |
|
| Post surgical spine infection | Surgical and medical procedures | Non-systematic Assessment | Patient to orthopedic spine surgery service for the diagnosis of acute paraplegia secondary to post-surgical infection. |
|
| Motor vehicle accident | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient visited ER after MVC; fractured right acetabular and multiple rib fractures |
|
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment | patient complaining of chest pain |
|
| Total left hip anthroplast | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | patient had hip replacement |
|
|
| progressive renal insufficiency | Endocrine disorders | Non-systematic Assessment | Pt had known history of kidney disease and required dialysis post-operatively |
|
| Paroxysmal atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Patient developed fibrillation during dialysis |
|
| Enterotomies | Surgical and medical procedures | Non-systematic Assessment | bowel enterotomies occurred during intraoperative lysis of adhesions |
|
| Hematoma | Surgical and medical procedures | Non-systematic Assessment | Patient's incision began to drain. |
|
| inguinal hernia repair | Skin and subcutaneous tissue disorders | Non-systematic Assessment | patient had groin pain and CT scan showed inguinal hernia. Repaired with surgery |
|
| Superficial skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Cellulitis near incision |
|
| Whiplash | Nervous system disorders | Non-systematic Assessment | whiplash due to MVA |
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| Abdominal pain | Surgical and medical procedures | Non-systematic Assessment | reports abdominal pain or tenderness |
|
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment | patient went to cardiology for chest pain and diagnosed with CAD |
|
| Ureteral stone | Renal and urinary disorders | Non-systematic Assessment | patient reported flank and abdominal pain. CT scan showed ureteral stone |
|
| abdominal wall bulge | Surgical and medical procedures | Non-systematic Assessment | patient reported abdominal wall bulge |
|
| rectal bleeding | Renal and urinary disorders | Non-systematic Assessment | blood in stool and rectal bleeding |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | patient reported constipation that lead to diarrhea and vomiting |
|
Not provided
Not provided
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| Difference |
|
| Difference |
|
| Difference |
|
| Difference |
|
| Difference |
|
| Difference |
|
| Do you feel your hernia has come back? |
|
| Do you feel your hernia has come back? |
|