Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial)

Jonathan Douissard, Jeremy Meyer, Arnaud Dupuis, Andrea Peloso, Julie Mareschal, Christian Toso, Monika Hagen, Jonathan Douissard, Jeremy Meyer, Arnaud Dupuis, Andrea Peloso, Julie Mareschal, Christian Toso, Monika Hagen

Abstract

Background: The objective of the present study is to compare the outcomes open PVHR and robotic PVHR.

Methods/design: The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1-5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence.

Discussion: Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, 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.In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR.

Trial registration: The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.

Keywords: Da Vinci; DaVinci; Epigastric hernia; Hernia repair; Laparotomy; Mesh; PVHR; Repair; Robot; Technique; Trial; Umbilical hernia; Ventral hernia.

© 2020 The Authors.

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Source: PubMed

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