Versius or Laparoscopic Abdominal Hernia REpair (VOLARE)

Joanne Turner

Status: Withdrawn

Conditions: Abdominal Surgery; Abdominal Hernia

Treatments: Procedure: Laparoscopic; Procedure: Robotic

Study type: Observational

Funder types: Other

Identifiers

NCT05253586

MKUH-RD-019

Details and patient eligibility

About

This trial will compare laparoscopic and robotic-assisted abdominal hernia repairs, using the Versius® system. We will initially aim to recruit 60 patients (20 patients in the laparoscopic arm and 40 in the robotic arm) in order to assess the ergonomic impact of each modality on the operating surgeon. This aims to provide in vivo information on whether robotic surgery provides any advantages to the operating surgeon. This trial will also be used to assess the feasibility of recruitment to a future larger study, and any data collected will be used as pilot data.

Full description

This study has been designed to assess the ergonomics of Versius® assisted surgery in comparison with laparoscopic surgery in the management of abdominal hernias. The study will randomise 60 patients who require repair of an abdominal hernia and have been deemed suitable for a minimally invasive approach. Patients will be randomised to receive either laparoscopic or Versius® robotic assisted surgery but will be informed that it will be attempted via a minimally invasive approach that could include either of these two subtypes of minimally invasive surgery.

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years

• Need for abdominal hernia repair surgery

  • Incisional
  • Congenital

• Deemed suitable for minimally invasive surgery

Exclusion criteria

• Patients who are unable to consent
• Prisoners
• Patients in need of emergency surgery
• Patients with a hernial defect size of over 7cm

Trial design

0 participants in 2 patient groups

Laparoscopic Arm

Description:

This cohort of participants will have their procedure completed by a human surgeon.

Treatment:

Procedure: Laparoscopic

Robotic Arm

Description:

This cohort of participants will have their procedure completed by the Versius Surgical Robotic System.

Treatment:

Procedure: Robotic