Open Versus Robotic Retromuscular Ventral Hernia Repair
- Conditions
- Ventral Hernia
- Registration Number
- NCT03007758
- Lead Sponsor
- Prisma Health-Upstate
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- Ventral or incisional hernia measuring ≥ 7 cm and ≤ 15 cm.
- At least one of the following risk factors: Body Mass Index > 30, Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, current smoker (within 1 month)
- Current abdominal wall infection
- Presence of ileostomy, colostomy, or ileal conduit
- Center for Disease Control wound class 3 or 4
- Hernia defect < 7 cm or >15 cm
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Composite Outcome of Diagnosis of Surgical Site Occurrence or Infection, Hospital Readmission, or Hernia Recurrence Through study completion, an average of 2 years 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.
- Secondary Outcome Measures
Name Time Method All Surgical Site Occurrences Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.
Surgical Site Occurrences Requiring Procedural Intervention Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years Surgical site occurrence (SSO) is defined as all wound complications that occur after a surgical procedure but are not surgical site infections
All Surgical Site Infections Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.
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 Measured at study enrollment Body Mass Index
Hernia Width measured at surgery Width of Hernia
Hernia Length measured at surgery Length of Hernia
Quality of Life Via Questionnaire - 30 Days assessed at Baseline and Post-operatively at 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.
Quality of Life Via Questionnaire - 6 Through 12 Months 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. 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.
Quality of Life Via Questionnaire - 24 Months assessed at Baseline and Post-operatively at 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.
Pain Score - 30 Day Patient Reported Outcomes assessed at Baseline and Post-operatively at 30 days. 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.
Ventral Hernia Recurrence Inventory 1 Year assessed at Baseline and Post-operatively at 12 months. 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.
Ventral Hernia Recurrence Inventory 2 Years assessed at Baseline and Post-operatively at 24 months 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.
Hernia Recurrence assessed Post-operatively as 24 months 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.
Conversion to Open Assessed at index surgery. Robotic surgeries converted to open surgeries.
Pain Score - 6 or 12 Month Patient Reported Outcomes assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores 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.
Pain Score - 24 Month Patient Reported Outcomes assessed at Baseline and Post-operatively at 24 months 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.