Open Versus Robotic Retromuscular Ventral Hernia Repair

Browse trials for

• Hernia, Ventral 254
• Incisional Hernia 219

Keywords

• Hernia repair
• Robotic hernia repair
• Open hernia repair
• Incisional hernia

Hernia, Ventral

254 studies on the registry are indexed under Hernia, Ventral; 46 are open to participants now.

This study's enrollment of 101 is close to the median of 95 across 159 interventional studies indexed under Hernia, Ventral.

Lead sponsor

Prisma Health-Upstate is the lead sponsor of 74 studies on the registry; 7 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Study arms

• Active comparator
  robotic ventral hernia repair (VHR)

  Robotic VHR

  Procedure: robotic ventral hernia repair

• Active comparator
  open ventral hernia repair (VHR)

  Open VHR

  Procedure: open ventral hernia repair

Interventions

• Procedureopen ventral hernia repair

  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.

• Procedurerobotic ventral hernia repair

  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.

Primary outcomes

1. 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.

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

Secondary outcomes

1. 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.

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

2. 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

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

3. 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.

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

4. Surgical Site Infections Requiring Procedural Intervention

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

5. Length of Stay at Hospital Measured in Days

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

6. Operative Time (Procedure Start to Procedure Finish Measured in Minutes)

   Time frame: Day of surgery

7. Cost for Hospital Charges From Billing Office

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

8. BMI

   Body Mass Index

   Time frame: Measured at study enrollment

9. Hernia Width

   Width of Hernia

   Time frame: measured at surgery

10. Hernia Length

    Length of Hernia

    Time frame: measured at surgery

11. 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.

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

12. 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.

    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.

13. 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.

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

14. 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.

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

15. 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.

    Time frame: assessed at Baseline and Post-operatively at 6-12 months; data for 6 and 12-month pain scores were combined for analysis.

16. 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.

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

17. 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.

    Time frame: assessed at Baseline and Post-operatively at 12 months.

18. 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.

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

19. 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.

    Time frame: assessed Post-operatively as 24 months

20. Conversion to Open

    Robotic surgeries converted to open surgeries.

    Time frame: Assessed at index surgery.

Baseline characteristics

6 further baseline measures are reported on the registry.

Study documents

• Protocol and statistical analysis plan · Apr 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All patients will be entered prospectively into the Americas Hernia Society Quality Collaborative (AHSQC) database.