Umbilical and epigastric hernia repair, whether considering primary or incisional hernias, are associated with a high risk of local complications, with global rate of surgical complications at one month up to 25%. To date three techniques are used. Open ventral hernia repair (OVHR) is associated with a high risk of surgical site infection, wound dehiscence, and hematoma, but is the main technique due to advantages such as cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic hernia repair (LHR) reduces these complications but implies to place a mesh in intra-peritoneal position which is known to lead to adhesions, requires advanced laparoscopic skills, does not allow the closure of the defect due to limited range of motion, and can lead to excessive pain and pain-killers consumption due to the use of "tackers" to hold the mesh in place. Robotic ventral hernia repair (RVHR) uses the same laparoscopic access as LHR but thanks to the extended range of motion given by the robotic system allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills. LHR is of very low adoption in Geneva University Hospital for the aforementioned inconvenient. Moreover, the final result of the procedure is not the same than with OVHR or RVHR, since the defect is not primarily closed and the mesh is in intra-peritoneal position. OVHR and RVHR , however, lead to the same final result and only defer by the access type (direct vs. laparoscopic). RVHR is gaining rapid popularity and adoption in the United States but remains a costly solution. It is unclear whether the supposed benefits for the patients of RVHR overwhelm the extra costs and time, especially by reducing the complication rate and consecutive in-hospital and out-hospital costs. Moreover, increasing experience of the robotic system in Geneva University Hospital has led to a significant costs and time reduction in other robotic procedures and could eventually make RVHR cost effective if its clinical benefits were to be proven. This study aims at demonstrating that robotic trans-abdominal pre-peritoneal (rTAPP) primary ventral hernia repair leads to lower surgical site complication rate than the same procedure performed through standard open approach (OVHR), while being an acceptable solution from an economic, operative time and functional standpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
162
Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
Visceral surgery department - Geneva University Hospital
Geneva, Switzerland
Surgical site complication
Yes or no
Time frame: At 31 days after surgery
Detailed surgical site complications
Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)
Time frame: At 31 days after surgery
General complications, not directly related to surgical site
Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome)
Time frame: At 31 days after surgery
General pain: Visual Analogue Scale
Evaluated using Visual Analogue Scale (VAS, scale from 0 to 10, higher score mean a worse outcome))
Time frame: At 31 days after surgery
Painkillers consumption
Recorded from patient's medical record for in-hospital stay for out-hospital period will be evaluated with consumption recall at each visit
Time frame: At 31 days after surgery
Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL)
Using European Hernia Society Quality of Life (EuraHS-QoL) ( scale from 0-90, with the lower scores being the most favorable outcome)
Time frame: At 31 days after surgery
Quality of life score
Using European Hernia Society Quality of Life (EuraHS-QoL) form (scale from 0-90, with the lower scores being the most favorable outcome)
Time frame: At 31 days after surgery
In-hospital costs
Hospitalization costs including medications, care and labs, cost of the procedure, diagnosis related group class, total amount billed to the insurance. Derived using REKOLE® method.
Time frame: At day 31 after surgery
Out-hospital costs
Consults and drugs Estimated based on hospital's billing data.
Time frame: At day 31 after surgery
Early recurrence at 1 month
Evaluated by physical evaluation
Time frame: At day 31 after surgery
Defect size
Measured with ruler
Time frame: During surgery
Number of device related adverse events by the operating surgeon
Surgical complications which are identified by the operating surgeon as directly related to malfunction of the robotic system
Time frame: During surgery
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