Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair (VOLTAIRE)

NHS Foundation Trust

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: Robotic; Procedure: Procedure/Surgery: Laparoscopic

Study type: Observational

Funder types: Other

Identifiers

NCT05262374

MKUH-RD-021

Details and patient eligibility

About

This trial will compare laparoscopic and robotic-assisted inguinal 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 inguinal hernias. The study will randomise 60 patients who require repair of an inguinal 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. The randomisation will occur on a 2:1 basis, with 2 patients allocated to the robotic arm for every 1 patient allocated to the laparoscopic arm. Laparoscopic surgery is already a well-established technique, and therefore the study team believe more valuable data about the outcomes of robotic surgery will be obtained with this randomisation ratio given that no prior studies have been undertaken using this robotic platform. All surgeons in the study will be required to have been involved in at least 20 cases performed using the relevant modality, whether for the robotic or laparoscopic cohorts.

Data will be collected at four key timepoints; recruitment, intraoperatively, at discharge and again at 14 days following intervention. Feasibility outcomes will include willingness to be recruited to study (acceptability), willingness for patient to undergo desired randomised operative approach (acceptability/concordance), withdrawal of patients (non-concordance), study retention (retention rates), and the usefulness and limitations of outcome measures.

Enrollment: 60 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• Need for inguinal hernia repair surgery
• Deemed suitable for minimally invasive surgery

Exclusion criteria

• Patients who are unable to consent
• Prisoners
• Patients in need of emergency surgery
• Patients with inguinoscrotal or recurrent inguinal hernias

Trial design

60 participants in 2 patient groups

Laparoscopic Arm

Description:

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

Treatment:

Procedure: Procedure/Surgery: Laparoscopic

Robotic Arm

Description:

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

Treatment:

Procedure: Robotic