Robotic Versus Open Primary Ventral Hernia Repair

Study Overview
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Brief Summary
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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.

Official Title
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Robotic Versus Open Primary Ventral Hernia Repair: a Randomized Controlled Trial

Conditions
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Ventral Hernia

Intervention / Treatment
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* Procedure: Robotic ventral hernia repair
* Procedure: Open ventral hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Informed Consent as documented by signature Aged 18 years or older Undergoing primary umbilical or epigastric hernia repair of size between 1cm and 5cm +/-5mm, with mesh reinforcement, in the Visceral Surgery Department of the University Geneva Hospital Exclusion Criteria: Patients under corticosteroids or other immunosuppressive treatment Pregnancy or breastfeeding Intention to become pregnant during the course of the study Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential Incisional hernia and/or substantial history of intra-abdominal surgery Upon anesthesiologist evaluation, clinically significant concomitant disease states which require to shorten operative time at maximum Upon anesthesiologist evaluation, clinically significant concomitant disease states being a contra-indication to laparoscopic approach and/or general anesthesia Known or suspected non-compliance, drug or alcohol abuse, Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia of the participant Previous enrolment into the current study Enrolment of the investigator, his/her family members, employees and other dependent persons

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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No

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic ventral hernia repair<br> | Procedure: Robotic ventral hernia repair<br>* Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement<br>|
| Active Comparator: Open ventral hernia repair<br> | Procedure: Open ventral hernia repair<br>* Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site complication | Yes or no | At 31 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detailed surgical site complications | Classified according to aforementioned Clavien-Dindo's scoring system (scale from 1 to 5, higher score mean a worse outcome) | 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) | 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)) | 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 | 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) | 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) | 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. | At day 31 after surgery | 
| Out-hospital costs | Consults and drugs Estimated based on hospital's billing data. | At day 31 after surgery | 
| Early recurrence at 1 month | Evaluated by physical evaluation | At day 31 after surgery | 
| Defect size | Measured with ruler | 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 | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Open ventral hernia repair, Robotic ventral hernia repair, Surgical site complications, Esthetic satisfaction, Pain, Pain-killers consumption, Costs, Operative time, Early hernia recurrence, General complications