Open Versus Robotic Retromuscular Ventral Hernia Repair

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.

Time frame: Through study completion, an average of 2 years

Population: 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.

Surgical site occurrence is defined as all wound complications that occur after a surgical procedure but are not surgical site infections.

Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

Population: 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.

Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

Population: 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

Time frame: Measured at study enrollment

Population: 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.

Robotic surgeries converted to open surgeries.

Time frame: Assessed at index surgery.

Population: Patient who are randomized to receive an open ventral hernia repair were not assessed for Conversion to Open

Time frame: Through study completion, an average of 2 years

Population: 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

Time frame: measured at surgery

Population: 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.

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.

Time frame: assessed Post-operatively as 24 months

Population: 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.

Width of Hernia

Time frame: measured at surgery

Population: 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.

Time frame: Time from procedure until discharge, an expected range of 2 to10 days

Population: 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.

Time frame: Day of surgery

Population: 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.

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.

Time frame: assessed at Baseline and Post-operatively at 24 months

Population: 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.

Time frame: 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.

Time frame: 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 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.

Time frame: assessed at Baseline and Post-operatively at 24 months

Population: 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-\[(20/12)\*(sum of response on all 12 questions)\]).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.

Time frame: assessed at Baseline and Post-operatively at 30 days

Population: 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.

Time frame: 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.

Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

Population: 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

Time frame: Post-operatively: 2 weeks, 6 weeks, 6 months, 1 year, 2 years

Population: 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.

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.

Time frame: 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.

Time frame: assessed at Baseline and Post-operatively at 24 months

Population: 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.