Versius or Laparoscopic TransAbdominal Inguinal Hernia REpair

NCT ID: NCT05262374

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-09
• Study Completion Date: 2024-04-05

Brief Summary

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.

Detailed 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.

Conditions

Inguinal Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Laparoscopic Arm

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

Procedure/Surgery: Laparoscopic

Intervention Type: PROCEDURE

Surgeon

Robotic Arm

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

Robotic

Intervention Type: PROCEDURE

Versius system.

Interventions

Procedure/Surgery: Laparoscopic

Surgeon

Intervention Type: PROCEDURE

Robotic

Versius system.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton Keynes University Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barrie Keeler

Role: PRINCIPAL_INVESTIGATOR

Colorectal surgeon

Locations

Surgical Division

Milton Keynes, , United Kingdom

Countries

United Kingdom

Other Identifiers

MKUH-RD-021

Identifier Type: -

Identifier Source: org_study_id