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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rTAR | Active Comparator | Patients randomized in the robotic group will undergo the technique for intra-and perioperative management for robotic complex abdominal wall repair cases as used in the center. A robotic surgical platform (da Vinci X or da Vinci Xi Surgical System, Intuitive Surgical, Aubonne, Switzerland) will be used and a retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference. |
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| oTAR | Active Comparator | Patients randomized in the open group will undergo the technique for intra-and perioperative management for open complex abdominal wall repair cases as used in the center. A retrorectus +/- retromuscular mesh placement performed. Use of component separation or not will be at the discretion of the surgeon. In principle the posterior layer and the anterior fascia will be closed avoiding a bridging technique. Drain management and mesh fixation are left to the surgeon's preference. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| incisional hernia repair | Procedure | Incisional hernia repair for the treatment of wide ventral incisional hernias. |
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| Measure | Description | Time Frame |
|---|---|---|
| Length of postoperative hospital stay | Length of postoperative hospital stay | hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Skin-to-skin operative time | Skin-to-skin operative time from first incision until last skin suture | Per-operative (minutes) |
| Conversion rate | Conversion rate from the robotic-assisted approach to the open approach |
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Inclusion Criteria:
- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maaike Vierstraete, MD | Contact | +3293329500 | maaikevierstraete@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Filip Muysoms, MD PhD | Clinical research center Maria Middelares | Principal Investigator |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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a multicenter international randomized controlled trial
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This is an open-label Randomized Controlled Trial (RCT) where the patient, surgeon, research coordinators and hospital staff will be aware of the treatment arm after randomization. As the open approach is performed using a large midline incision, whereas the robotic approach applies only 6 or 7 small incisions (or less if no posterior component separation is needed), blinding of patients and physicians is difficult.
Evaluation of the radiographic imaging of the abdominal wall at 24 months (MRI or CT scan) will be done by radiologists at the local participating center blinded to the randomized treatment arm. This will be a blinded evaluation for the presence or absence of hernia recurrence. Data analysis will be performed in a blinded manner by an independent statistician.
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| Per-operative |
| Surgical site related complications | Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions | 30 days |
| Readmission rate | Readmission rate | 30 Days and 3 months postoperative |
| Post-anesthetic discharge scoring system | Minimum score is 0, maximum score is 12. The higher the score, the better the outcome. | From the end of surgery (last skin suture) until discharge, assessed up to 20 days |
| Postoperative visual analogue scale pain score | Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome. | From the end of surgery (last skin suture) until discharge, assessed up to 20 days |
| EuraHS 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 Scale | 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 | 30 days, 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 | 30 days, 3 Months, 12 months, 24 months, 60 months |
| Postoperative complications | Postoperative complications classified acoording to the Clavien-Dindo Classification | 30 days |
| Reoperation rate | Reoperation rate | 30 days |