NCT04171921

Robotic Versus Open Primary Ventral Hernia Repair

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: University of Geneva, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventral Hernia

Interventions

Type	Name	Description
PROCEDURE	Robotic ventral hernia repair	Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
PROCEDURE	Open ventral hernia repair	Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement

Timeline

• Start date: 2019-11-01
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2019-11-21
• Last updated: 2023-05-03

Locations

1 site across 1 country: Switzerland