Clinical trial NCT04171921: Robotic Versus Open Primary Ventral Hernia Repair
Official title: Robotic Versus Open Primary Ventral Hernia Repair: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventral Hernia
Keywords: 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
Lead sponsor: University of Geneva, Switzerland
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Surgical site complication
timeFrame: At 31 days after surgery
Secondary outcomes:
measure: Detailed surgical site complications
timeFrame: At 31 days after surgery
measure: General complications, not directly related to surgical site
timeFrame: At 31 days after surgery
measure: General pain: Visual Analogue Scale
timeFrame: At 31 days after surgery
measure: Painkillers consumption
timeFrame: At 31 days after surgery
measure: Esthetic satisfaction: European Hernia Society Quality of Life (EuraHS-QoL)
timeFrame: At 31 days after surgery
measure: Quality of life score
timeFrame: At 31 days after surgery
measure: In-hospital costs
timeFrame: At day 31 after surgery
measure: Out-hospital costs
timeFrame: At day 31 after surgery
measure: Early recurrence at 1 month
timeFrame: At day 31 after surgery
measure: Defect size
timeFrame: During surgery
measure: Number of device related adverse events by the operating surgeon
timeFrame: During surgery
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Visceral surgery department - Geneva University Hospital
Study officials:
affiliation: University of Geneva, Geneva University Hospital
name: Jonathan Douissard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Douissard J, Meyer J, Dupuis A, Peloso A, Mareschal J, Toso C, Hagen M. Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial). Int J Surg Protoc. 2020 Apr 4;21:27-31. doi: 10.1016/j.isjp.2020.03.004. eCollection 2020.