Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias

Study Overview
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Brief Summary
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In the treatment of ventral incisional hernias, a mesh repair in the retromuscular plane is considered as the gold standard. To allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias, component separation techniques are increasingly being used. When compared to anterior component separation, posterior component separation by transversus abdominis release (TAR) seems to decrease postoperative wound problems. While laparoscopic techniques pose significant difficulties to perform TAR minimally invasively (mainly due to ergonomic and technical reasons), these limitations seem to be overcome by robotic platforms. Initial retrospective patient series report on significantly shorter postoperative hospital stay and fewer complications after robotic transversus abdominis release (rTAR), when compared to open transversus abdominis release (oTAR). High-quality prospective evidence on rTAR is currently lacking.

Official Title
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Robotic Versus Open Comparison in the Surgical Treatment of Wide Abdominal Wall Hernias: an Open-label Multicenter International Randomized Controlled Trial

Conditions
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Ventral Incisional Hernia

Intervention / Treatment
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* Procedure: Component separation (transversus abdominis release)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients with a ventral incisional hernia of more than 8 centimeters in width Exclusion Criteria: Emergency surgery Pregnancy Age<18 Incisional hernia repair after open abdomen or enterocutaneous fistula Active wound infection Previous anterior or posterior component separation Absence of a signed informed consent Patients unable to give informed consent or complete the quality-of-life assessment (due to language barriers or intellectual capacity) Primary ventral hernias

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An open-label multicenter international European randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic-assisted repair of wide ventral incisional hernia<br>Robotic | Procedure: Component separation (transversus abdominis release)<br>* Component separation by transversus abdominis release, to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias.<br>|
| Active Comparator: Open repair of wide ventral incisional hernia<br>Open | Procedure: Component separation (transversus abdominis release)<br>* Component separation by transversus abdominis release, to allow for adequate medialization of the fascial borders and a complete closure of the defect in case of large incisional hernias.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | Length of postoperative hospital stay | From date of operation until the date of discharge, assessed up to 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin-to-skin operative time | Skin-to-skin operative time | Per-operative (minutes) | 
| Conversion rate | Conversion rate | Per-operative | 
| Postoperative complication rate | Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions | 30 days | 
| Readmission and reoperation rate | Readmission and reoperation rate | 30 Days | 
| Post-anesthetic discharge scoring system | Minimum score is 0, maximum score is 12. The higher the score, the better the outcome. | Immediately after the surgery | 
| Postoperative visual analogue scale pain score | Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome. | Immediately after the surgery | 
| Quality of Life Scoring | Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome. | Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months | 
| Body image score | Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome). | Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months | 
| Hernia recurrence | Hernia recurrence | 3 Months, 12 months, 24 months, 60 months | 
| Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence | Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence | 3 Months, 12 months, 24 months, 60 months |