Abdominal Wall Hernia, Ventral Incisional Hernia
Conditions
Keywords
Abdominal Wall Hernia, robotic TAR (rTAR), open TAR (oTAR), transversus abdominis release (TAR)
Brief summary
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.
Interventions
PROCEDUREincisional hernia repair
Incisional hernia repair for the treatment of wide ventral incisional hernias.
Sponsors
Algemeen Ziekenhuis Maria Middelares
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
a multicenter international randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All patients requiring treatment of a wide ventral incisional hernia (of more than 8 centimetres in width)
Exclusion criteria
* Pregnant or suspected pregnancy * Not-curatively treated malignancy, with life expectancy less than 24 months * Patients unable to give informed consent or complete study specific questionnaires * Emergency surgery * Primary ventral hernia repair * Exclusively lateral hernias not involving the midline * Incisional hernia repair after open abdomen or enterocutaneous fistula * Active wound infection * Previous anterior or posterior component separation * Patients with an existing ostomy * Patients with a life expectancy of less than 24 months * Patients suspected of being unable to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of postoperative hospital stay | hours from the end of surgery (last skin suture) until discharge, assessed up to 20 days | Length of postoperative hospital stay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin-to-skin operative time | Per-operative (minutes) | Skin-to-skin operative time from first incision until last skin suture |
| Conversion rate | Per-operative | Conversion rate from the robotic-assisted approach to the open approach |
| Surgical site related complications | 30 days | Surgical site infection - surgical site occurrence - surgical site occurrence requiring procedural interventions |
| Readmission rate | 30 Days and 3 months postoperative | Readmission rate |
| Post-anesthetic discharge scoring system | From the end of surgery (last skin suture) until discharge, assessed up to 20 days | Minimum score is 0, maximum score is 12. The higher the score, the better the outcome. |
| Postoperative visual analogue scale pain score | From the end of surgery (last skin suture) until discharge, assessed up to 20 days | Minimum score is 0, maximum score is 10. The higher the score, the worse the outcome. |
| EuraHS Quality of Life Scoring | Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months | Minimum score is 0, maximum score is 90. The higher the score, the worse the outcome. |
| Body Image Scale | Preoperatively, 30 days, 3 months, 12 months, 24 months, 60 months | Minimum score is 0, maximum score is 10. A higher score means a higher level of body image disturbance (worse outcome). |
| Hernia recurrence | 30 days, 3 Months, 12 months, 24 months, 60 months | Hernia recurrence |
| Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence | 30 days, 3 Months, 12 months, 24 months, 60 months | Reoperation for hernia recurrence or abdominal surgery not for hernia recurrence |
| Postoperative complications | 30 days | Postoperative complications classified acoording to the Clavien-Dindo Classification |
| Reoperation rate | 30 days | Reoperation rate |
Contacts
PRINCIPAL_INVESTIGATORFilip Muysoms, MD PhD
Clinical research center Maria Middelares
Outcome results
None listed